| CTRI Number |
CTRI/2025/03/081534 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
22/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Management of Infertility by Vrishya Yoga and lifestyle modifications |
|
Scientific Title of Study
|
Vrishya effect of Mashatmaguptadi Modaka along with lifestyle modifications in the management of Kshinashukra w.s.r. to Quality of Semen - A Randomized Placebo-controlled Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahesh Jadhav |
| Designation |
MD Scholar |
| Affiliation |
MD Scholar |
| Address |
Department of Swasthavritta, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat 361008
Department of Swasthavritta, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat 361008
Jamnagar
GUJARAT
361008
India |
| Phone |
9892292800 |
| Fax |
|
| Email |
jadhavmahesh2206@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Shalinee Kumari Mishra |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar |
| Address |
Department of Swasthavritta, Institute of Teaching and Research in Ayurveda, Jamnagar
Jamnagar
GUJARAT
361008
India |
| Phone |
9664540469 |
| Fax |
|
| Email |
drshalinee@itra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Vd Shalinee Kumari Mishra |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar |
| Address |
Department of Swasthavritta, Institute of Teaching and Research in Ayurveda, Jamnagar
GUJARAT
361008
India |
| Phone |
9664540469 |
| Fax |
|
| Email |
drshalinee@itra.edu.in |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda, near B division Police station, Jamnagar, Gujarat, 361008 |
|
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Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Institute of Teaching and Research in Ayurveda, near B division Police station, Jamnagar, Gujarat, India 361008 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mahesh Jadhav |
Institute of Teaching and Research in ayurveda, Jamnagar |
OPD no.14, C block, Institute of Teaching and Research in ayurveda, Jamnagar, Gujarat, 361008
Jamnagar
GUJARAT |
9892292800
jadhavmahesh2206@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute of Teaching and Research in Ayurveda, Jamnagar |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N461||Oligospermia. Ayurveda Condition: SUKRAKSHAYAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mashatmaguptadi Modaka , Reference: Vagbhata. Astanga Samgraha. edited by Kaviraj Atrideva Gupta Vidyalankar, Uttara Sthana chapter 50. Ver. 38, Varanasi: Chaukhambha Krishnadas Academy.p-424 , Route: Oral, Dosage Form: Modaka , Dose: 20(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Milk mixed with Sugar), Additional Information: Same Lifestyle Modifications will be given to participants as stated in comparator arm. | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: Brahma Muhurta Jagrana, Malatyaga, Abhyanga, Vyayama, Snana., Ritucarya: NA, Acara Rasayana:Brahmacharya, Deaddiction, Other:Ratricharya-
Samvahana, Dugdhapana, Sushayya shayan., Pathya/Apathya:yes, Pathya:Vrishya Ahara vihara, Apathya:Avrishya ahara vihara |
|
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Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Male |
| Details |
1. Person willing to participate in the study.
2. Married Male patients trying to conceive for more than 1 year without success.
3. Age between 25 to 45 years.
4. Total Sperm count less than 39 million/ ml (below normal limit)
5. Sperm Concentration less than 16 million/ ml (below normal limit)
6. Abnormality in any semen parameter like Sperm volume, Sperm motility, Sperm morphology, etc. (below normal limit)
7. Patient with more than 3 symptoms of Kshinashukra. (Daurbalya, Mukhashosha, etc).
8. Patient with or without hormonal abnormalities in testosterone, LH, FSH.
|
|
| ExclusionCriteria |
| Details |
1. Person not willing to participate in the study.
2. Unmarried / Divorced / widower.
3. Patients with age below 25 and above 45 years.
4. Total Sperm count more than 39 million/ ml (above normal limit)
5. Sperm Concentration more than 16 million/ ml (above normal limit)
6. Patient of aspermia and azoospermia, teratospermia, haematospermia
7. Patients suffering from Varicocele, undescended testis, cystic fibrosis, any obstruction in reproductive or urinary track, accessory sex gland infection, STD, etc.
8. Systemic diseases like chronic renal failure (CRF), Hypertension (BP more than 140/90 mmHg), Diabetes mellitus (RBS more than 140 mg/dl), Hyperlipidaemia, cardiac diseases (H/O MI, IHD)
9. Genetic disorders like Klinefelter syndrome.
10. Patient taking treatment for major psychiatric illness.
11. History of previous medication and trauma.
12. Patients having Hematuria (Blood in the urine), Chronic Cystitis, UTI, Kidney Stone, Bladder and urethral Stones.
13. Known case of HIV, Hepatitis, CA.
14. Patient with BMI more than 30.
15. Patient suffering from urethral stricture, phimosis, meatal stenosis, hypospadias, epispadias.
16. Patient with severe Shukrakshaya lakshanas like Sarakta Shukra Darshanam, Medra Doomayana, Shukra Avisarga, etc. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To prove Vrishya effect of Mashatmaguptadi Modaka by improvement in semenogram i.e. improvement in quality of semen (increased sperm count, morphology and motility) in Kshinashukra. |
Group A - 60 Days
Group B - 60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Improvement in physical sign and symptoms.
2. Improvement in the quality of life of infertile couple. (FertiQOL scale)
3. Improvement in the Quality of Life (WHOQOL) – BREF. |
60 days |
|
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Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Introduction: Ayurveda has described many principles such as Dinacharya, Ritucharya, Sadvritta, Trayopasthambha, Rasayana, Vajikarana, etc. to maintain one’s health. Mashatmaguptadi Modaka contains most of drugs which are in use as Aharadravyas. This will give therapeutic as well as dietary benefits. Vajikarana Chikitsa makes a man sexually healthy and he is able to copulate for longer period with increased frequency. If a healthy person uses Vrishya Dravyas regularly, he can achieve virtue, wealth, pleasure and fame. It also gives rise to offspring which is the resort of these qualities.
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