| CTRI Number |
CTRI/2026/02/103113 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the effectiveness of an Ayurvedic formulation in women with ovulation-related menstrual problems. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study To Assess The Efficacy Of Methikadya Churna In Vandhyatva With Special Reference To Anovulatory Cycles |
| 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 Divya Pawar |
| Designation |
PhD Scholar In Striroga And Prasutitantra |
| Affiliation |
YMT Ayurved College And Hospital, Kharghar, New Mumbai |
| Address |
Y.M.T. Ayurvedic Medical College and Hospital, Kharghar, Navi Mumbai, Maharashtra, India
YMT Ayurved College And Hospital, Kharghar, New Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9011145777 |
| Fax |
|
| Email |
pawardivya29794@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Pawar |
| Designation |
PhD Scholar In Striroga And Prasutitantra |
| Affiliation |
YMT Ayurved College And Hospital, Kharghar, New Mumbai |
| Address |
YMT Ayurved College And Hospital, Kharghar, New Mumbai
YMT Ayurved College And Hospital, Kharghar, New Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9011145777 |
| Fax |
|
| Email |
pawardivya29794@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Pawar |
| Designation |
PhD Scholar In Striroga And Prasutitantra |
| Affiliation |
YMT Ayurved College And Hospital, Kharghar, New Mumbai |
| Address |
YMT Ayurved College And Hospital, Kharghar, New Mumbai
YMT Ayurved College And Hospital, Kharghar, New Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9011145777 |
| Fax |
|
| Email |
pawardivya29794@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
YMT Ayurvedic Medical College and Hospital |
| Address |
Y M T Ayurvedic Medical College and Hospital Kharghar Navi Mumbai Maharashtra India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Divya Pawar |
G D Pol Foundation YMT Ayurvedic Medical College Kharghar Navi Mumbai |
Department Of Strirog And Prasuti Tantra
G D Pol Foundation
YMT Ayurvedic Medical College
Sector Four
Kharghar
Navi Mumbai
Maharashtra
Pin Code Four One Zero Two One Zero
Raigarh
MAHARASHTRA |
09011145777
pawardivya29794@gmail.com |
| Dr Divya Pawar |
YMT Ayurved College And Hospital Kharghar New Mumbai |
YMT Ayurved College And Hospital
Department Of Strirog And Prasuti Tantra
Kharghar
Navi Mumbai
Maharashtra
Raigarh
MAHARASHTRA |
09011145777
pawardivya29794@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee YMT Ayurved College And Hospital Kharghar Navi Mumbai |
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 | Comparator Arm (Non Ayurveda) | | - | Clomiphene Citrate | Administered from 5th day of menstrual cycle for 5 days per cycle, for 3 consecutive cycles. Number of patients: 46. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Methikadya Churna, Reference: Gadanigraha Pratham Khanda Churnadhikar 03/27 - 30, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 12 Days, anupAna/sahapAna: Yes(details: Warm Water), Additional Information: Every menstrual cycle for 3 consecutive months; total patients: 46 |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1 Known cases of infertility due to anovulation and polycystic ovarian disease
2 Patients with age between eighteen to forty years having infertility
3 Both primary and secondary infertility patients will be selected randomly |
|
| ExclusionCriteria |
| Details |
1 Patients suffering from acute or chronic medical and systemic diseases such as tuberculosis heart disease hypothyroidism and hyperthyroidism
2 Patients having congenital anomalies of uterus such as unicornuate uterus uterus didelphys bicornuate uterus septate uterus and arcuate uterus
3 Patients having pelvic diseases such as fibroids benign or malignant tumors of ovary sexually transmitted diseases pelvic inflammatory disease endometriosis cervicitis and salpingitis |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evidence of ovulation assessed by follicular study and endometrial thickness by ultrasonography. |
Assessment will be done at baseline before initiation of treatment and at four weeks eight weeks and twelve weeks after initiation of treatment corresponding to three consecutive menstrual cycles. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ovulation pattern assessed by ultrasonography |
At the end of each menstrual cycle |
| Endometrial thickness assessed by ultrasonography |
At the end of each menstrual cycle |
| Change in follicular development assessed by ultrasonography |
At the end of each menstrual cycle |
| Conception during the study period |
During treatment and follow up period |
| Regularity of menstrual cycle assessed by interval duration amount of flow and associated pain |
At the end of each menstrual cycle and at the end of three menstrual cycles |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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 |
|
Date of First Enrollment (India)
|
01/03/2026 |
| 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="0"
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
|
This Randomized Controlled Clinical Trial Aims To Evaluate The Efficacy Of Methikadya Churna In Women With Infertility Due To Anovulatory Cycles. The Primary Objective Is To Assess Improvement In Ovulation And Conception Rates. Participants Will Undergo Standard Hormonal And Imaging Assessments Before And After Treatment To Evaluate Ovulatory Function And Fertility Outcomes. |