| CTRI Number |
CTRI/2025/12/099991 [Registered on: 31/12/2025] Trial Registered Prospectively |
| Last Modified On: |
29/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of Dhatryadi yog Medicine in infertility caused by Anovulation |
|
Scientific Title of Study
|
A Randomized controlled trial to assess the ovulatory effect of dhatryadi yog in the management of vandhya (primary infertility) with special reference to Anovulation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nishigandha Sameer Pol |
| Designation |
Associate Professor |
| Affiliation |
Dr G.D.Pol Foundation Y.M.T. Ayurvedic medical college, kharghar |
| Address |
Dr G.D.Pol Foundation,Y.M.T.Ayurvedic Medical College,Gynac Department,3rd Floor,Institutional Area,Sector 4,Kharghar ,Navi Mumbai,410210.
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8108150590 |
| Fax |
|
| Email |
nishigandhabhavake@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Chandrakant Mehere |
| Designation |
Professor And HOD |
| Affiliation |
Dr G.D.Pol Foundation Y.M.T. Ayurvedic medical college, kharghar |
| Address |
Dr G.D.Pol Foundation,Y.M.T.Ayurvedic Medical College,Gynac Department,3rd Floor,Institutional Area,Sector 4,Kharghar ,Navi Mumbai,410210.
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9930940403 |
| Fax |
|
| Email |
seema.mehre@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishigandha Sameer Pol |
| Designation |
Associate Professor |
| Affiliation |
Dr G.D.Pol Foundation Y.M.T. Ayurvedic medical college, kharghar |
| Address |
Dr G.D.Pol Foundation,Y.M.T.Ayurvedic Medical College,Gynac Department,3rd Floor,Institutional Area,Sector 4,Kharghar ,Navi Mumbai,410210.
Raigarh
MAHARASHTRA
410210
India |
| Phone |
08108150590 |
| Fax |
|
| Email |
nishigandhabhavake@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr G.D.Pol Foundation,Y.M.T.Ayurvedic Medical College,Gynac Department,3rd Floor,Institutional Area,Sector 4,Kharghar ,Navi Mumbai,Maharashtra,India-410210. |
|
|
Primary Sponsor
|
| Name |
Nishigandha Sameer Pol |
| Address |
1101/4, S.K.P.,Near Prime Mall,Sector 12 ,Kharghar,Navi Mumbai |
| Type of Sponsor |
Other [Self] |
|
|
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 Nishigandha Sameer Pol |
Y.M.T. Ayurved Medical College And HospitalL |
Dr G.D.Pol Foundation,Y.M.T.Ayurvedic Medical College,Gynac Department,3rd Floor,Institutional Area,Sector 4,Kharghar ,Navi Mumbai,410210.
Raigarh
MAHARASHTRA |
08108150590
nishigandhabhavake@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N970||Female infertility associated withanovulation. Ayurveda Condition: VANDHYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: DHATRYADI YOG, Reference: GADA NIGRAHA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 12 Days, anupAna/sahapAna: Yes(details: GODUGDHA), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | CLOMIPHENE CITRATE | 50 MG ,OD,FOR 5DAYS |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. All patients with c/o Primary Infertility with Anovulatory cycle.
2. Patients having regular or irregular menses. |
|
| ExclusionCriteria |
| Details |
1. Congenital anomalies of uterus, ovaries, cervix, vagina(female reproductive organs).
2. Fibroids, Ovarian Tumour, Premature Ovarian Failure, CA Cervix.
3. Known case of systemic diseases like DM, Hypothyroidism, Hyperthyroidism. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess and compare the ovulatory effect of Dhatryadi Yog and
Clomiphene Citrate in management of Vandhya (Primary Infertility) with special reference
to Anovulation. |
At Baseline, 4 Weeks,8 Weeks And 12 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the complete literature on ovulation as well as Vandhya available in texts.
2.To suggest a safe & cost effective medicine for anovulatory cycles.
3. To validate what the ayurvedic granthakaras have described as a medicine for garbha
janan/ conception. |
At Baseline, 4 Weeks,8 Weeks And 12 Weeks |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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)
|
09/01/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
|
Brief Summary
|
THE PRESENT STUDY IS A PhD TOPIC. BY PhD SCH.DR NISHIGANDHA SAMEER POL AND GUIDE NAME DR SEEMA MEHERE
TITLE- A Randomized Controlled Trial to assess the ovulatory effect of Dhatryadi
yog in the management of Vandhya (Primary Infertility) with special
reference to Anovulation. Group A - 12 gm Of Dhatryadi Yog with godoogdha before breakfast (Apan kal) from fifth
day of menses for 12 days. Group B – Clomiphene Citrate 50 mg once in a day to be given from fifth day of menses for
five days.
TOTAL DURATION OF TRIAL IS 1YR AND 6 MONTHS |