Passion Flower GP (30)

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Passion flower GP is a natural non addictive calming remedy that contains standardized 4:1 passion flower extract (aerial parts) (3.5% vitexin) to guarantee its potency and consistency.

The product has been manufactured using high quality pure herbs and the technology that ensures all their beneficial properties intact, in strict compliance with GMP and TÜV regulations.

Passion Flower GP is an excellent natural calming product with passion flower (Passiflora incarnata L.) created by Santegra®. 

Passiflora incarnata is native to tropical and sub-tropical parts of Central and South America. The herb has long been used by Native Central and North Americans for medicinal purposes. Spanish conquerors of Mexico and South America learned about its healing properties in sixteenth century. 

The name “passion flower” was inspired by an amazing colored flower. According to a legend, flowers of this plant reminded Spanish conquistadors of a crown of thorns, symbolized sufferings of Christ, and, thus, served as a sign of approval for their efforts to gain new lands. 

The genus Passiflora incarnata has long been used in traditional herbal medicine for the treatment of insomnia and anxiety in Europe, and as a sedative tea in North America. Furthermore, this plant has been used for analgesic, anti-spasmodic, anti-asthmatic, wormicidal and sedative purposes in Brazil; and for the treatment of dysmenorrhea, epilepsy, insomnia, neurosis and neuralgia in Turkey. In Poland, this plant has been used to treat hysteria and neurasthenia; in America, it has been used to treat diarrhea, dysmenorrhea, neuralgia and insomnia. Passiflora incarnata L. has also been used to cure subjects affected by opiate dependence in India. (1)

Today, passion flower is official in the national Pharmacopeias of France, Germany, and Switzerland, and also monographed in the British Herbal Pharmacopoeia and the British Herbal Compendium, the European Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States.

The British Herbal Compendium indicates its use for sleep disorders, restlessness, nervous stress, and anxiety. Other uses include neuralgia and nervous tachycardia (Bradley, 1992). The German Standard License for passionflower tea indicates its use for nervous restlessness, mild disorders of sleeplessness, and gastrointestinal disorders of nervous origin (Bradley, 1992; Wichtl and Bisset, 1994). ESCOP indicates its use for tenseness, restlessness, and irritability with difficulty in falling asleep (ESCOP, 1997).

Key constituents in passion flower include flavonoids (vitexin, kaempferol, quercetin, rutin), indole alkaloids (harman, harmin, harmol), glycosides, amino acids (including GABA), etc.

Passion Flower GP contains standardized passion flower (Passiflora incarnata) 4:1 aerial part extract (3.5% vitexin) to guarantee its effectiveness.

Passiflora incarnata has antioxidant properties. (2)

A number of studies have shown an anti-anxiety activity of Passiflora incarnata. (3, 13)
Passion flower extract appears to be effective in improving stress resistance and quality of life in patients suffering from nervous restlessness, and is well tolerated. (4)

Passiflora incarnata is a good sleeping aid, it is safe and does not cause dependency. (5, 6)

Passion flower has positive influence on nervous system, especially during hormonal changes. It is recommended for perimenopausal and menopausal complaints (such as mental anxiety, insomnia, irritability, headaches, etc.). (7,8)

Passion flower is recommended in anti-alcohol programs, it may also help fight tobacco addiction.  Passiflora incarnata extract may be an effective adjuvant agent in the management of opiate, alcohol and nicotine withdrawal. (9, 10)
Effect of passion flower in alleviating ADHD symptoms was tested in double-blind, randomized clinical trial. Passion flower can be used under doctor’s supervision for hyperactive children, at the conditions connected with attention disorders, and pediatric nervousness and excitability. (11)

The results of the animal study concluded that Passiflora incarnata extract suppresses seizures and ameliorates its associated post-ictal depression. (14, 15)

Passiflora incarnata has been reported to possess antihypertensive effects. (15)

Passion flower may positively influence memory. The results of long-term oral administration of Passiflora incarnata have shown the reduced anxiety and dose-dependent improvement of memory in animal model. (16)

Per one capsule:

standardized Passion flower (Passiflora incarnata) 4:1 extract (aerial parts) (3.5% vitexin)(equivalent to 1200 mg of crude herb) - 300 mg.

30 capsules in blister packs.

As a dietary supplement take 1-2 capsules with a large glass of water with meals for one month.

 

Contraindication

Individual intolerance, asthenia. 
If you are pregnant, consult your physician prior to taking this product.
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Vitexin is one of the most important constituents in passion flower.

Vitexin has a variety of pharmacological effects, including antioxidant (Bai et al., 2016), anti‐inflammatory (Choi et al., 2014; Nikfarjam, Hajiali, Adineh, & Nassiri‐Asl, 2017), antibacterial (Quílez et al., 2010; Das et al., 2016), antiviral (Fahmy et al., 2020), antinociceptive (Borghi et al., 2013), hepatoprotective (Kim, Chin, Lim, Kim, & Kim, 2004), cardioprotective (Dong et al., 2013), and neuroprotective effects (Yang, Yang, Zhang, Tian, Liu, & Zhao, 2014; Hosseinzadeh & Nassiri‐Asl, 2017).


Vitexin has been proven capable of donating electrons and has acted as a good radical scavenger.



 

Neurological disorders
Vitexin has antiepileptic effects on pilocarpine model. (Aseervatham, Suryakala, Doulethunisha Sundaram, Bose, & Sivasudha, 2016). Vitexin compound showed dose‐dependent neuroprotective effects against hypoxia/reoxygenation‐induced oxidative stress (Yang, Tan, et al., 2014).
Vitexin ameliorated neurological defects in cerebral ischemia/reperfusion (Wang et al., 2015).
Pretreatment with vitexin (2 mg/kg, i.v.) suppressed the apoptosis induced by middle cerebral artery occlusion (MCAO) (Jiang, Dai, & Cui, 2018).
Vitexin (45 mg/kg, i.p.) showed significant neuroprotective effects following hypoxic/ischemic injury (HI) and reduced brain edema, neuronal cell death, the brain infarct volume, and blood–brain barrier (BBB) breakdown in rat pups (Min et al., 2015).

Memory impairment
Passiflora incarnata L. extract improves neurogenesis and memory function. (Qi, Chen, Shan, Nie, & Wang, 2020)

Antinociceptive and anti‐inflammatory activities
Vitexin inhibits inflammation‐associated pain and can also inhibit 91% of the acetic acid‐induced writhing response and pain‐like behavior induced by phenyl‐p‐benzoquinone, complete Freund's adjuvant, capsaicin (Borghi et al., 2013).
Cardiovascular injury

Vitexin has cardioprotective effects and decreases the elevation of the ST segment of ECG and reduces myocardial infarct size in myocardial ischemia‐reperfusion in rats (Dong et al., 2013).
Vitexin is found in food sources and is used as an active component with herbal supplement. (17)

European Pharmacopoeia, 2012 recommends Passion Flower extract containing no less than 1,5% total flavonoids calculated as vitexin. 

Passion Flower GP contains the standardized Passion Flower (Passiflora incarnata) aerial part extract (4:1) with 3.5% vitexin.

“A double-blind randomized trial compared the efficacy of Passiflora incarnata extract with oxazepam in the treatment of generalized anxiety disorder (GAD). The study was performed on 36 out-patients diagnosed with GAD. Patients were allocated in a random fashion: 18 to the Passiflora extract 45 drops/day, and 18 to oxazepam 30 mg/day plus placebo drops for a 4-week trial. RESULTS: Passiflora extract and oxazepam were effective in the treatment of generalized anxiety disorder. No significant difference was observed between the two protocols at the end of trial. Oxazepam showed a rapid onset of action. On the other hand, significantly more problems relating to impairment of job performance were encountered with subjects on oxazepam. 
The results suggest that Passiflora extract is an effective drug for the management of generalized anxiety disorder, and the low incidence of impairment of job performance with Passiflora extract compared to oxazepam is an advantage." (3)

The passion flower dried ethanolic extract investigated in this non-interventional study has well-documented calmative effects and good tolerability. We investigated the effects of this extract on the stress resistance (resilience) and quality of life (QoL) of patients suffering from nervous restlessness.
Adult patients aged ≤ 95 years with the diagnosis 'nervous restlessness' were treated for 12 weeks with a dried ethanolic extract of passion flower (Passiflora incarnata L.). Standardized questionnaires were used to evaluate the resilience (RS-13), QoL (EQ-5D including EQ-VAS), and the addiction potential (BDEPQ).
After 12 weeks of treatment, significant (p < 0.001) improvements were measured in the patients' resilience (RS-13: from 52.1 to 67.7 points) and QoL (EQ-VAS: from 47.9 to 75.0 points). Also, the mean BDEPQ score was significantly (p < 0.001) reduced (from 23.0 to 19.3 points). The mean values of all accompanying symptoms (inner restlessness, sleep disturbance, exhaustion, fear, lack of concentration, nausea, trembling, and palpitation) improved significantly (p < 0.001). Tolerability of treatment was rated as 'very good' or 'good' by the majority of the patients. Three cases of mild adverse events (tiredness) were reported.
Conclusion: The passion flower extract investigated in the present study appears to be effective in improving resilience and QoL in patients suffering from nervous restlessness and is well tolerated. (4)

Passiflora incarnata is a traditional herbal sedative, anxiolytic and a popular sleep aid used for the treatment of sleep disturbance. The aim of the present study was to investigate the efficacy of Passiflora incarnata herbal tea on human sleep, as measured using sleep diaries validated by polysomnography (PSG). This study featured a double-blind, placebo-controlled, repeated-measures design with a counterbalanced order of treatments (passionflower vs placebo tea), separated by a 1 week 'washout' period. Forty-one participants (18-35 years) were exposed to each treatment for a week, whereby they consumed a cup of the tea and filled out a sleep diary for 7 days and completed Spielberger's state-trait anxiety inventory on the seventh morning. Ten participants also underwent overnight PSG on the last night of each treatment period. Of six sleep-diary measures analyzed, sleep quality showed a significantly better rating for passionflower compared with placebo (t(40) = 2.70, p < 0.01). These initial findings suggest that the consumption of a low dose of Passiflora incarnata, in the form of tea, yields short-term subjective sleep benefits for healthy adults with mild fluctuations in sleep quality. (5)

The results of a double-blind randomized controlled trial of clonidine plus Passiflora extract vs. clonidine plus placebo in the outpatient detoxification of 65 opiates addicts suggested that Passiflora extract may be an effective adjuvant agent in the management of opiate withdrawal. A total of 65 opiates addicts were assigned randomly to treatment with Passiflora extract plus clonidine tablet or clonidine tablet plus placebo drop during a 14-day double-blind clinical trial. All patients met the DSM IV criteria for opioid dependence. The fixed daily dose was 60 drops of Passiflora extract and a maximum daily dose of 0.8 mg of clonidine administered in three divided doses. The severity of the opiate withdrawal syndrome was measured on days 0, 1, 2, 3, 4, 7 and 14 using the Short Opiate Withdrawal Scale (SOWS).
Both protocols were equally effective in treating the physical symptoms of withdrawal syndromes. However, the Passiflora plus clonidine group showed a significant superiority over clonidine alone in the management of mental symptoms.  (9)

Nicotine, a bioactive component of tobacco, is highly addictive. Numerous therapies have been developed for smoking cessation, and all have met with limited success. Our laboratory has previously shown that an extract of Passiflora incarnata Linn. antagonized the expression of nicotine locomotor sensitization in rats.
This study examined the ability of vitexin, a flavonoid found in P. incarnata, to ameliorate the signs of nicotine sensitization in rats. Male Wistar rats were administered 0.4 mg/kg nicotine or vehicle (n = 16-18 per group) once a day for four consecutive days. Nicotine administration produces sensitization of locomotor activity. On the fifth day, locomotor activity was monitored as rats from each treatment group were administered either 30 or 60 mg/kg vitexin or its vehicle (n = 4-6 per group) 30 min before a challenge dose of 0.4 mg/kg nicotine.
The challenge dose of nicotine resulted in locomotor activity in rats sensitized to nicotine for 4 days that was approximately twice that measured in rats treated with vehicle during the sensitization phase. Rats sensitized to nicotine and then treated with 60 mg/kg vitexin prior to the nicotine challenge exhibited a level of locomotor activity equivalent to the vehicle-treated controls. Vitexin antagonized the expression of nicotine locomotor sensitization in rats as the whole extract did in the previous study. Conclusion: Vitexin should be examined in future studies to evaluate its potential for treating nicotine addiction in humans. (10)

Effect of passion flower in alleviating ADHD symptoms was tested in double-blind, randomized clinical trial. 34 children with ADHD were randomized to receive tablets of Passiflora (0.04 mg/kg/day, twice daily) or methylphenidate (1 mg/kg/day, twice daily), dosed on a weight-adjusted basis, for 8 weeks. Both parent and teacher rating scores revealed no significant difference in the clinical benefits of Passiflora and methylphenidate treatment in ADHD children over the course of the trial (F = 0.007, df = 1, and p = 0.93; and F = 0.006, df = 1, and p = 0.94, resp.). Moreover, side effect profile of Passiflora was less compared with methylphenidate. (11)

Anxiety symptoms are frequently observed in dental patients, whether they are undergoing simple or more invasive procedures such as surgery. This research aimed to compare the effects of Passiflora incarnata and midazolam for the control of anxiety in patients undergoing mandibular third molar extraction.
Forty volunteers underwent bilateral extraction of their mandibular third molars in a randomized, controlled, double-blind, crossover clinical trial. Passiflora incarnata (260 mg) or midazolam (15 mg) were orally administered 30 minutes before surgery. The anxiety level of participants was evaluated by questionnaires and measurement of physical parameters, including heart rate (HR), blood pressure (BP), and oxygen saturation (SpO2).
Considering each procedure independently, there were no significant differences between the protocols in BP, HR, and SpO2. Over 70% of the volunteers responded that they felt quiet or a little anxious under both protocols. With midazolam, 20% of the participants reported amnesia (not remembering anything at all), while Passiflora showed little or no ability to interfere with memory formation.
Conclusions: Passiflora incarnata showed an anxiolytic effect similar to midazolam and was safe and effective for conscious sedation in adult patients who underwent extraction of their mandibular third molars. (13)

Passiflora incarnata L. (Passifloraceae) has been used for the treatment of epilepsy in several traditional systems of medicine. The present study was designed to investigate dual protective effect of the hydroethanolic extract of Passiflora incarnata in pentylenetetrazol (PTZ)-induced seizure and associated post-ictal depression.
Different groups of mice were administered with repeated subconvulsive doses of PTZ (50mg/kg; i.p.) at an interval of 5 days for 15 days. From 5th to 15th day the animals in different groups were administered daily with varying doses of hydroethanolic extract of Passiflora incarnata (150, 300, and 600mg/kg; i.p.), diazepam (2mg/kg; i.p.) and vehicle. On every 5th day, after PTZ treatment, seizure severity (score) was noted. Following convulsive episodes, the locomotor activity (using actophotometer) and immobility period (using forced swim test) were also determined. On 15th day after behavioral assessment, the brain serotonin and noradrenaline levels were determined using spectrofluorometric methods.
Treatment with the extract significantly (p<0.05) reduced the seizure severity and immobility period as compared to vehicle control, in a dose and time-dependent manner. Moreover, the extract treatment retained the serotonin and noradrenaline levels of the brain. Conclusions: The results of present study concluded that the hydroethanolic extract of Passiflora incarnata suppress PTZ-induced seizures, and ameliorates its associated post-ictal depression, which has been found to be get worsened with the standard antiepileptic drug, diazepam. (14)

Passiflora incarnata L. has been used as a medicinal plant in South America and Europe since the 16th century. Previous pharmacological studies focused mainly on the plant's sedative, anxiolytic, and anticonvulsant effects on the central nervous system and its supporting role in the treatment of addiction.
The aim of the present study was to evaluate the behavioral and neurochemical effects of long-term oral administration of P. incarnata. The passionflower extract (30, 100, or 300 mg/kg body weight/day) was given to 4-week-old male Wistar rats via their drinking water. Tests were conducted after 7 weeks of treatment. Spatial memory was assessed in a water maze, and the levels of amino acids, monoamines, and their metabolites were evaluated in select brain regions by high performance liquid chromatography (HPLC). We observed reduced anxiety and dose-dependent improvement of memory in rats given passionflower compared to the control group. (16)

1. Miroddi M, Calapai G. Navarra M, Minciullo PL, Gangemi S. Passiflora incarnata L.: Ethnopharmacology, clinical application, safety and evaluation of clinical trials. J Ethnopharmacol. 2013;150:791-804.

2. Suvarna P Ingale, Sanjay B Kasture. Protective Effect of Standardized Extract of Passiflora incarnata Flower in Parkinson’s and Alzheimer’s Disease.  Anc Sci Life. 2017 Apr-Jun; 36(4): 200–206.

3. Akhondzadeh S, Naghavi HR, Vazirian M, Shayeganpour A, Rashidi H, Khani M. Passionflower in the treatment of generalized anxiety: a pilot double-blind randomized controlled trial with oxazepam. J Clin Pharm Ther. 2001 Oct;26(5):363-7

4. Judith Gibbert, Fabian Kreimendahl, Jennifer Lebert, Reinhard Rychlik, Inga Trompetter. Improvement of Stress Resistance and Quality of Life of Adults with Nervous Restlessness after Treatment with a Passion Flower Dry Extract. Complement Med Res. 2017;24(2):83-89.

5. A Ngan, R Conduit. A double-blind, placebo-controlled investigation of the effects of Passiflora incarnata (passionflower) herbal tea on subjective sleep quality. Phytother Res. 2011 Aug;25(8):1153-9.

6. Gwang-Ho Kim, Yehlim Kim, Sunmi Yoon, Sung-Jo Kim, Sun Shin Yi. Sleep-inducing effect of Passiflora incarnata L. extract by single and repeated oral administration in rodent animals. Food Sci Nutr. 2019 Dec 19;8(1):557-566.

7. Israel D, Youngkin EQ. Herbal therapies for perimenopausal and menopausal complaints. Pharmacotherapy . 1997;17:970-984.

8. Fahami F, Asali Z, Aslani A, Fathizadeh N. A comparative study on the effects of Hypericum Perforatum and passion flower on the menopausal symptoms of women referring to Isfahan city health care centers. Iran J Nurs Midwifery Res. 2010;15:202–207

9. Akhondzadeh S, Kashani L, Mobaseri M, Hosseini SH, Nikzad S, Khani M. Passionflower in the treatment of opiates withdrawal: a double-blind randomized controlled trial. J Clin Pharm Ther. 2001 Oct;26(5):369-73

10. Samantha Bedell, Jacob Wells, Qinfeng Liu, Chris Breivogel. Vitexin as an active ingredient in passion flower with potential as an agent for nicotine cessation: vitexin antagonism of the expression of nicotine locomotor sensitization in rats. Pharm Biol. 2019 Dec;57(1):8-12.

11. Akhondzadeh, Mohammadi, Momeni. Passiflora incarnata in the teartment of attention-deficit hyperactivity disorder in children and adolescents. Therapy 2(4):609-614 · July 2005.

12. Sita Sharan Patel, Neelesh Kumar Verma, Karunakaran Gauthaman. Review Article Passiflora Incarnata Linn: A Review on Morphology, Phytochemistry and Pharmacological Aspects. Phcog Rev. Vol, 3, Issue 5, 186-192, 2009.

13. L-P Dantas, A de Oliveira-Ribeiro, L-M de Almeida-Souza, F-C Groppo. Effects of Passiflora incarnata and midazolam for control of anxiety in patients undergoing dental extraction. Med Oral Patol Oral Cir Bucal. 2017 Jan 1;22(1):e95-e101.

14. Bhupinder Singh, Damanpreet Singh, Rajesh Kumar Goel. Dual protective effect of Passiflora incarnata in epilepsy and associated post-ictal depression. J Ethnopharmacol. 2012 Jan 6;139(1):273-9.

15. Protko N.N. Passiflora (Passiflora incarnata) in general practice. Belarussian Medical Academy of Post-Graduate Education, Minsk. Medical News. Issue 7, 2016.

16. Katarzyna Jawna-Zboińska, Kamilla Blecharz-Klin, Ilona Joniec-Maciejak, Adriana Wawer, Justyna Pyrzanowska, Agnieszka Piechal , Dagmara Mirowska-Guzel, Ewa Widy-Tyszkiewicz. Passiflora incarnata L. Improves Spatial Memory, Reduces Stress, and Affects Neurotransmission in Rats. Phytother Res. 2016 May;30(5):781-9.

17. Fatemeh Babaei, Armita Moafizad, Zahra Darvishvand, Mohammadreza Mirzababaei, Hossein Hosseinzadeh, and Marjan Nassiri‐Asl. Review of the effects of vitexin in oxidative stress‐related diseases. Food Sci Nutr. 2020 Jun; 8(6): 2569–2580.