Passion Flower GP - Clinical Trials
|I Product Info||I Ingredients
||I Recommended Use
||I Clinical Trials
||I Research Brief
Indication: irritability, sleep disturbance, susceptibility to cramps. hyperactivity in children, anti-alcoholic program.
Actions: helps to calm down, reduces irritability and nervousness, helps to decrease arterial blood pressure, promotes restful sleep, relieves cramps and spasms, can be used in antialcoholic program.
Ingredients (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.
Low USA domestic & international
Passion Flower GP - Clinical Trials:
Human studies of Passiflora species as a sedative/anxiolytic have been conducted. In a multicenter, double-blind trial of 91 patients, Passiflora exhibited statistically significant differences when compared with placebo in the treatment of adjustment disorder with anxious mood. (6)
“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." (7)
A number of Indian studies have shown a clear anxiolytic (anti-anxiety) activity of Passiflora incarnata in both animals and humans.
Since ancient time passion flower is used for treatment of nervousness and sleeplessness, scientists have made an attempt to establish with the help of chromatography, which active substances of Passion flower are responsible for this positive influence.
Sedative effect was observed in mice with an artificially produced anxiety with the use of 10 mg/kg methanol Passiflora extract. Active components have been presented in the form of blue and turquoise fluorescing spots in ultra-violet light range of 366 nm. It is supposed, that bioactivity of passion flower is caused by phytocomponents with benzo flavonoid nucleus. (8)
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)
The passion flower extract demonstrates sedative effect and can be used as a sedation before surgeries that has been shown in one of experiments. (10)