Clinical study on Ayuvigo Forte Capsules in patients with less sperm count
- Conditions
- Oligospermia,
- Registration Number
- CTRI/2017/06/008799
- Lead Sponsor
- Welex Laboratories Pvt Ltd
- Brief Summary
It is an open label, multi-center, prospective, interventional, clinical study to evaluate efficacy and safety of Ayuvigo Forte Capsules in 30 patients suffering from Oligospermia. The study will be conducted at three sites in India. The dose of the drug would be 2 capsules two times daily orally after meals with a cup of milk for 90 days. The primary outcome measures will be to assess efficacy and safety of Ayuvigo Forte Capsules in patients suffering from Oligospermia by assessing changes in total sperm count on Day -7, Day 0, and Day 90. The secondary objectives will be to assess Changes in semen volume, Sperm motility with progressive sperm motility, total number of spermatozoa per ejaculate, Sperm Morphology, viability of spermatozoa, serum levels of total and free testosterone, serum level of LH, FSH, spontaneous achieved pregnancies, Change in subjective parameters, Global assessment for overall improvement by investigator and patient, tolerability of study drug by assessing ADRs, laboratory parameters on Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90.
Results:
Inthe present study a total of 51 subjects were screened. There were 20 screenfailures as they did not meet the inclusion / exclusion criteria. Of thesesubjects, 31 subjects were included in study and they received the studymedicine. 1 subject dropped out from the study due to loss to follow up. A totalof 30 subjects were considered as completers or efficacy evaluable cases. Allthe subjects who took even a single dose of the study drug were considered forsafety evaluation.
Of the 30 subjects who completed thestudy the average age of the subjects was 32.16 ± 5.80 years. Of these subjects,13 subjects were in the age group of 20-30 years, 15 subjects in the age groupof 31- 40 years and 2 subjects were in the age group of 41-45 years.
*Prakruti*wise distribution of subjects in the study showed that there were 8 subjects of*Vata Pitta Prakruti*, 3 subjects of *Vata Kapha Prakruti*, 10subjects of *Pitta Vata Prakruti*, 7 subjects of *Pitta Kapha Prakruti*,1 subject each of *Kapha Pitta Prakruti* and *Tridoshaj Prakruti*.
There is asignificant increase in the total mean sperm count per ml which was 7.93 ±4.06 at baseline visit and significantlyincreased to 15.11 ±16.68 at theend of 90 days. There was a 90.54% increase in the total sperm count in 90days.
It was observedthat that mean progressive sperm motility at baseline visit was 21.75 ±12.26which increased to 29.07± 15.07 after day 90. This increase in progressive premmotility was found to be significant. There was a 33.65% increase in thepercentage of progressive sperm motility in 90 days.
The totalsperm count per ejaculate showed a significant increase from baseline visitwhich was 14.31±9.44 and increased significantly to 28.46 ± 33.55 at the end of 90 days. There was 98.88%increase in the total sperm count per ejaculate.
There was no major abnormality observed in the sperm morphology at thebaseline visit and at the end of the study period i.e. 90 days. Majority of thesubjects reported to have normal sperm morphology at both the baseline and 90days visit.
Evaluation ofsperm viability showed that the immediate mean viability at baseline was 47.35± 9.37 which increased significantly to 55.56 ±8.56 after 90 days. Theviability after one hour was 30.29 ±7.17 at baseline visit which showed aslight increase to 31.67 ±7.86 at day 90. At the end of two hours also the meanviability was 20.88 ±6.18 at baseline visit which slightly increased to 21.11±4.71 at the end of 90 days. Thesechanges in viability at one hour and two hour were found to be statistically nonsignificant.
Assessment of Free and total Testesterone levelsshows that there was significant change in the free testosterone levels at day90. Serum free Testesterone level at the baseline visit was 10.10 ±7.21 mg/dlwhich significantly increased to 12.77 ±8.27 mg/dl after day 90 and totalTestesterone levels was 379 ±214.87at baseline which was increased to435.45 ±191.74 at the end of day 90. This increase was notstatistically significant.
There was no significant change in theSerum level of LH (Lutenizing Harmone) from baseline to day 90 of the studyperiod. The levels were within the normal range both at the baseline visit andat the end of 90 days of the study. The mean Serum level of LH (LutenizingHarmone) was 6.28±4.57 at baseline visit which increased slightly to 6.63±5.31at day 90.
There was nosignificant change in the FSH (follicle stimulating hormone) at the end of day90. The levels were within the normal rangeboth at the baseline visit and at the end of 90 days of the study. The mean FSH (follicle stimulating hormone)at baseline visit was 10.11±9.08 whichincreased to 11.45 ±12.41 at theend of day 90.
The meanProlactin at baseline visit was 6.48±2.67 which increased slightly to 6.84±3.19 at the end of day 90. The difference observedwas clinically non-significant. The levels were within the normal rangeboth at the baseline visit and at the end of 90 days of the study.
Assessment ofsome symptoms of low sperm count and sexual weakness as mentioned in Ayurvedawere also assessed on a subjective scale from baseline to monthly follow upvisits. It was observed that there was significant improvement in most of thesymptoms.
Safetyevaluation was done by evaluating bio-chemical parameters like CBC, Liverprofile, Kidney profile, Blood sugar. It was observed that there was noclinically significant change on these laboratory parameters when comparedbetween the baseline and 90 days visit. The values were within normal limits atboth the initial and final visits.
No clinicallysignificant change in vitals like Pulse rate, Temperature, Respiration rate andBlood Pressure (Systolic and Diastolic pressure) parameters from baseline toevery follow up visit of 30 days till the end of study i.e. day 90 wasobserved.
Assessmentof overall change of the study product as per the physician at the end of thestudy showed that 12 subjects (40%) had very much improvement, 07 (23.33%)subject showed much improvement, 05(16.66%) had minimal improvement while 3 subjects (10.%) reported no change. 1subject (3.33%) each showed minimal and much worsening.
Assessmentof overall change of the study product as per the subject at the end of thestudy showed that 13 subjects (43.33%) had very much improvement, 05 (16.66%)subject showed much improvement, 07(23.33%) had minimal improvement while 2 subjects (6.66%) reported no change.01 subject (3.33%) each reported minimal and much worsening.
Out of31 Subjects evaluated, 12 were reported to have AE. Therewere total 12 adverse events (AEs) such as abdominal discomfort, fever, cough,pain in abdomen, backache, bodyache and itching during the trial. Among 12 AEs,09 AEs were unrelated, 01AEs were possibly related whereas 02 AEs wereunlikely related to the study drug. No treatment or interruption of the studydrug or procedure was required to resolve these episodes. Allthe subjects who were evaluated from the safety parameter perspective showedexcellent to good safety for the study medication.
Conclusion:
The present study concludes thatregular use of Ayuvigo capsules in a dose of 2 capsules twice daily for aperiod of 90 days significantly increases total sperm count in subjectssuffering from oligospermia. The increase in sperm count was found to theextent of subjects having moderate oligospermia achieved almost normal levelsas prescribed in WHO guidelines (sperm count of >15 mill/ml). The increasein sperm count from baseline to 90 days was found to be 94.32%.
There was significant improvement insperm motility and viability as observed by the percentage of progressivesperms and the motility of sperms (immediate). There was a significant increasein the Free Testosterone levels over a period of 90 days.
Therewas a significant improvement in the clinical symptoms of low sperm count andsexual dysfunction as mentioned in Ayurveda.
Safetyassessment by record of AE, laboratory parameters like CBC, Liver profile,Renal profile, Lipid profile and Vitals showed excellent safety andtolerability of Ayuvigo capsules.
It canbe concluded from the present study that Ayuvigo capsules has spermatogenicactivity and can be useful in the management of infertility due toOligospermia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 30
- Sperm concentration less than 15 million per ml (WHO laboratory manual for the examination and processing of human semen, Fifth Edition, 2010) with normal sperm morphology, with or without sperm total motility less than 40 percent or sperm forward progressive motility less than 32 percent.
- Subjects should be in an active stable sexual relationship for the duration of study 3.
- Subjects who are willing to give informed consent and ready to comply with the protocol 4.
- Subjects who are ready to provide regular follow ups till the completion of the study.
- Subjects with major illnesses and sexual dysfunction due to anatomical, surgical or pharmacological causes 2.
- Subjects with total erectile failure or any other sexual disorder 3.
- Subjects with history of central nervous system disorders such as stroke, transient ischemic attacks or spinal cord injury or pelvic surgery 4.
- Subjects with clinical symptoms of scrotal varicocele and confirmed with USG and colour Doppler will be excluded from the study 6.
- Subjects with significant abnormal laboratory parameters.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate efficacy and safety of Ayuvigo Forte Capsules in patients suffering from Oligospermia by assessing Changes in total sperm count. Day -7, Day 0, Day 90
- Secondary Outcome Measures
Name Time Method 1. Changes in semen volume. 2. Changes in Sperm motility with progressive sperm motility.
Trial Locations
- Locations (3)
Ayurved Seva Sanghs Ayurved Mahavidyalaya
🇮🇳Nashik, MAHARASHTRA, India
KVTR Ayurvedic College Boradi
🇮🇳Dhule, MAHARASHTRA, India
Sunad Ayurveda, Chinchwad, Pune-411033
🇮🇳Pune, MAHARASHTRA, India
Ayurved Seva Sanghs Ayurved Mahavidyalaya🇮🇳Nashik, MAHARASHTRA, IndiaDr Devdatta A DeshmukhPrincipal investigator9422115844dadeshmukh1977@gmail.com