Вот описание исследования 2 фазы. Препарат тестировался на 350 мужчинах 21-40 лет с детьми (фертильные). Половина принимала 450 мг препарата 30 дней, вторая половина пользовалась презервативами. Произошла только одна беременность (есть основания полагать нарушения в приеме препарата). Через 30 дней после прекращения приема показатели спермы вернулись к норме. http://www.puregandarusa.com/content/14-study-on-contraceptive-effect-of-ethanol-ex-tracted-justicia-gendarussa-burmf-leaves-in-fertile-men-phase-2-clinical-trial
STUDY ON CONTRACEPTIVE EFFECT OF ETHANOL EXTRACTED JUSTICIA GENDARUSSA BURM.F. LEAVES IN FERTILE MEN: PHASE II CLINICAL TRIAL
Bambang Prajogo, EW, PhD1, Dyan Pramesti, MD, Master2 and Sri Musta’ina, Master2
1Dept. Pharmacognosy and Phytochemistry, Faculty of Pharmacy, Air- langga University; 2Reproductive Health Research Centre, School of Medicine Airlangga University
(Presented By: Dyan Pramesti, MD, Master)
Introduction and Objectives: Previous laboratory and clinical re- search suggest that Gendarussa has a contraceptive effect by prevent- ing fertilization without effecting sperm macroscopic and microscopic parameters. It may decrease human sperm hyaluronidase activity, and sperm proteins of weights 38 kDa and 41.5 kDa were missing in the treatment group. A similar pattern of missing proteins has been found in infertile males. We have carried out a phase 2 clinical trial with larger sample size and short duration of Gendarussa administration. To quan- tify the reduction of sperm hyaluronidase activity and the disappearance of proteins at 38 kDa and 41.5 kDa; to determine pregnancy rate; to monitor the safety and reversibility of Gendarussa.
Methods: 70% ethanol extract of alkaloid−free Justicia gendarussa leaves was used. The subjects were 350 healthy fertile men age 21−40 years, normozoospermia, had at least one child and fulfilled other in- clusion criteria. Single blind non−randomized method was undertaken. Group one (186 men) took 450 mg of Gendarussa capsules daily for 30 days; group two (164 men) took placebos and were instructed to use condoms. Semen analysis, hyaluronidase activity, sperm protein profile were examined before, during and after treatment. Subjects and their spouses were told to discontinue any contraception except Gendarussa or condoms. Group one was directed to have sexual intercourse three times during ovulation phase, after taking 20 capsules. The Ovulation phase was assessed individually for each couple. Spouses were asked to return after intercourse for post coital testing the next morning. Men in group two (placebo) were told to continue using condoms.
Results: Reduction of hyaluronidase activity by 5.81% and 6.47% af- ter 15 and 30 days respectively and disappearance of band 38kDa and 41,5kDa of sperm protein after 5 days treatment, in group one. One pregnancy was found (1/186 = 0.54%), with strong suspicion caused by Gendarussa failure or possibly by not taking the medicine as direct- ed. Hyaluronidase activity and sperm protein band 38kDa and 41,5kDa were found to be normal 30 days after stopping medication. Conclusions: 70% ethanolic extract of alkaloid−free Justicia gendarus- sa leaves is an effective male oral contraceptive method that is revers- ible and had no serious adverse effects. Further study is needed to de- termine its mechanism of action, but data strongly suggest that it acts as a contraceptive by preventing fertilization.