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CTRI Number  CTRI/2017/06/008799 [Registered on: 09/06/2017] Trial Registered Retrospectively
Last Modified On: 22/10/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Clinical study on Ayuvigo Forte Capsules in patients with less sperm count 
Scientific Title of Study   An Open Label, Multi-center, Prospective, Interventional, Clinical Study to Evaluate Efficacy and Safety of Ayuvigo Forte Capsules in Patients Suffering From Oligospermia  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
AYUVI/SPG /2016, Version 1.0, 31.08.2016  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Narendrakumar Bhanudas Mundhe  
Designation  Assistant Professor 
Affiliation  KVTR Ayurvedic College & Hospital, Boradi, Taluka: Shirpur. Dist.Dhule 
Address  Departmental of Kayachikitsa OPD No 5 Ground Floor, KVTR Ayurvedic College & Hospital Boradi Taluka Shirpur Dist Dhule

Dhule
MAHARASHTRA
424428
India 
Phone  09850378206  
Fax    
Email  drnbmundhe@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanjay Tamoli 
Designation  Director 
Affiliation  Target Institute of Medical Education and Research 
Address  Target Institute of Medical Education and Research 205, B Wing, Blue Diamond Society, Nayagoan, Dahisar West, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400068
India 
Phone  9322522252  
Fax    
Email  sanjaytamoli@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sanjay Tamoli 
Designation  Director 
Affiliation  Target Institute of Medical Education and Research 
Address  Target Institute of Medical Education and Research 205, B Wing, Blue Diamond Society, Nayagoan, Dahisar West, Mumbai

Mumbai (Suburban)
MAHARASHTRA
400068
India 
Phone  9322522252  
Fax    
Email  sanjaytamoli@hotmail.com  
 
Source of Monetary or Material Support  
Welex Laboratories 1002, Marathon Innova Nextgen, Off Ganpatrao kadam marg, Lower Parel, Mumbai -13 
 
Primary Sponsor  
Name  Welex Laboratories Pvt Ltd 
Address  1002, Marathon Innova Nextgen, Off Ganpatrao kadam marg, Lower Parel, Mumbai -13 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Devdatta A Deshmukh  Ayurved Seva Sanghs Ayurved Mahavidyalaya  OPD NO. 9, Ground Floor, Ayurved Research Department, Ayurved Seva Sanghs Ayurved Mahavidyalaya, Ganeshwadi, Panchvati, Nashik – 422003
Nashik
MAHARASHTRA 
9422115844

dadeshmukh1977@gmail.com 
Dr Narendrakumar B Mundhe  KVTR Ayurvedic College Boradi  KVTR Ayurvedic College BoradiOPD No 5 Ground Floor Department of Kayachikitsa KVTR Ayurvedic College Boradi Tal Shirpur Dist Dhule 425428
Dhule
MAHARASHTRA 
09850378206

drnbmundhe@gmail.com 
Dr Vidyadhar S Kumbhar  Sunad Ayurveda, Chinchwad, Pune-411033   Ground floor, Plot No. 6, Yashodhar Appartments, Above Krishna Street Link Road, Chinchwad - 411033
Pune
MAHARASHTRA 
9960075536

dr.vidyadhar24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Independent Ethics Committee, Dhanashree Hospital, Sangavi,Pune-61  Approved 
Institutional Ethics Committee, ASS Ayurved Mahavidyalaya, Nashik   Approved 
KVTR Ayurvedic College, Boradi, Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N461||Oligospermia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ayuvigo Forte Capsule  Ayuvigo Forte Capsule contains Mucona pruriens, Withania somnifera, Tribulus terrestris, Aspargus racemosus, Sida cordifolia, Asteracantha longifolia, Asparagus adscendens, Pueraria tuberosa, Convolvulus pluricaulis, Emblica officinalis, Anacyclus pyrethrum, Shilajeet, Piper longum, Myristica fragrans Dosage and Treatment Duration: Dosage form: 2 Capsules twice daily orally after meals with a cup of milk for a period of 90 days  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  45.00 Year(s)
Gender  Male 
Details  1. 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.
2. 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
 
 
ExclusionCriteria 
Details  1. 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 hypotension or uncontrolled hypertension, uncontrolled diabetes, hepatic impairment, renal impairment or hematological disorders
5. 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

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
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  
Outcome  TimePoints 
1. Changes in semen volume.
2. Changes in Sperm motility with progressive sperm motility.
3. Changes in total number of spermatozoa per ejaculate, Sperm Morphology, viability of spermatozoa.
4. Changes in serum total and free testosterone, serum LH, FSH
5. Spontaneous achieved pregnancies.
6. Change in subjective parameters
7. Global assessment for overall improvement by investigator and patient.
8. Tolerability of study drug
9. Laboratory parameters 
Day -7, Day 0, Day 30, Day 60, Day 90
 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   24/10/2016 
Date of Study Completion (India) 06/10/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Paper Published in Pharmacognosy Research (July-September 2019) 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  
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:

In the present study a total of 51 subjects were screened. There were 20 screen failures as they did not meet the inclusion / exclusion criteria. Of these subjects, 31 subjects were included in study and they received the study medicine. 1 subject dropped out from the study due to loss to follow up. A total of 30 subjects were considered as completers or efficacy evaluable cases. All the subjects who took even a single dose of the study drug were considered for safety evaluation.

Of the 30 subjects who completed the study 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 group of 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, 10 subjects of Pitta Vata Prakruti, 7 subjects of Pitta Kapha Prakruti, 1 subject each of Kapha Pitta Prakruti and Tridoshaj Prakruti.

There is a significant increase in the total mean sperm count per ml which was 7.93 ±4.06 at baseline visit and significantly increased to 15.11 ±16.68 at the end of 90 days. There was a 90.54% increase in the total sperm count in 90 days.

It was observed that that mean progressive sperm motility at baseline visit was 21.75 ±12.26 which increased to 29.07± 15.07 after day 90. This increase in progressive prem motility was found to be significant. There was a 33.65% increase in the percentage of progressive sperm motility in 90 days.

The total sperm count per ejaculate showed a significant increase from baseline visit which 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 the baseline visit and at the end of the study period i.e. 90 days. Majority of the subjects reported to have normal sperm morphology at both the baseline and 90 days visit.

Evaluation of sperm 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. The viability after one hour was 30.29 ±7.17 at baseline visit which showed a slight increase to 31.67 ±7.86 at day 90. At the end of two hours also the mean viability was 20.88 ±6.18 at baseline visit which slightly increased to 21.11 ±4.71 at the end of 90 days.  These changes in viability at one hour and two hour were found to be statistically non significant.

Assessment of Free and total Testesterone levels shows that there was significant change in the free testosterone levels at day 90. Serum free Testesterone level at the baseline visit was 10.10 ±7.21 mg/dl which significantly increased to 12.77 ±8.27 mg/dl after day 90 and total Testesterone levels  was 379 ±214.87 at  baseline which was increased to 435.45 ±191.74 at  the end of day 90. This increase was not statistically significant.

There was no significant change in the Serum level of LH (Lutenizing Harmone) from baseline to day 90 of the study period. The levels were within the normal range both at the baseline visit and at the end of 90 days of the study. The mean Serum level of LH (Lutenizing Harmone) was 6.28±4.57 at baseline visit which increased slightly to 6.63 ±5.31at day 90.

There was no significant change in the FSH (follicle stimulating hormone) at the end of day 90. The levels were within the normal range both 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 which increased to 11.45 ±12.41 at the end of day 90.

The mean Prolactin at baseline visit was 6.48±2.67 which increased slightly to 6.84±3.19 at the end of day 90. The difference observed was clinically non-significant. The levels were within the normal range both at the baseline visit and at the end of 90 days of the study.

Assessment of some symptoms of low sperm count and sexual weakness as mentioned in Ayurveda were also assessed on a subjective scale from baseline to monthly follow up visits. It was observed that there was significant improvement in most of the symptoms.

Safety evaluation was done by evaluating bio-chemical parameters like CBC, Liver profile, Kidney profile, Blood sugar. It was observed that there was no clinically significant change on these laboratory parameters when compared between the baseline and 90 days visit. The values were within normal limits at both the initial and final visits.

No clinically significant change in vitals like Pulse rate, Temperature, Respiration rate and Blood Pressure (Systolic and Diastolic pressure) parameters from baseline to every follow up visit of 30 days till the end of study i.e. day 90 was observed.

Assessment of overall change of the study product as per the physician at the end of the study 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. 1 subject (3.33%) each showed minimal and much worsening.

Assessment of overall change of the study product as per the subject at the end of the study 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 of 31 Subjects evaluated, 12 were reported to have AE. There were 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, 01 AEs were possibly related whereas 02 AEs were unlikely related to the study drug. No treatment or interruption of the study drug or procedure was required to resolve these episodes. All the subjects who were evaluated from the safety parameter perspective showed excellent to good safety for the study medication. 


Conclusion:

The present study concludes that regular use of Ayuvigo capsules in a dose of 2 capsules twice daily for a period of 90 days significantly increases total sperm count in subjects suffering from oligospermia. The increase in sperm count was found to the extent of subjects having moderate oligospermia achieved almost normal levels as prescribed in WHO guidelines (sperm count of >15 mill/ml). The increase in sperm count from baseline to 90 days was found to be 94.32%.

There was significant improvement in sperm motility and viability as observed by the percentage of progressive sperms and the motility of sperms (immediate). There was a significant increase in the Free Testosterone levels over a period of 90 days.

There was a significant improvement in the clinical symptoms of low sperm count and sexual dysfunction as mentioned in Ayurveda.

Safety assessment by record of AE, laboratory parameters like CBC, Liver profile, Renal profile, Lipid profile and Vitals showed excellent safety and tolerability of Ayuvigo capsules.

It can be concluded from the present study that Ayuvigo capsules has spermatogenic activity and can be useful in the management of infertility due to Oligospermia.



 
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