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
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
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"
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 onDay -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 showedmuch 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.