| CTRI Number |
CTRI/2024/10/076024 [Registered on: 29/10/2024] Trial Registered Prospectively |
| Last Modified On: |
28/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A single arm open labelled clinical study to evaluate the efficacy of Dhatryadi yoga in the management of Vandhyatva due to Irregular menses |
|
Scientific Title of Study
|
A SINGLE ARM OPEN LABELLED CLINICAL STUDY TO EVALUATE THE EFFICACY OF DHATRYADI
YOGA IN THE MANAGEMENT OF VANDHYATVA DUE TO ANOVULATORY CYCLE |
| 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 Pratiksha Sanjay Ghavate |
| Designation |
PG Scholar M.S Prasutitantra evum streerog |
| Affiliation |
Tilak Ayurved Mahavidyalay, pune |
| Address |
Tilak Ayurved Mahavidyalaya
1st floor Streerog and Prasutitantra Department
Rasta peth ,Pune 411011
Pune
MAHARASHTRA
411011
India |
| Phone |
7066792323 |
| Fax |
|
| Email |
pratikshaghavate2323@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradeep Musale |
| Designation |
Asso. Professor Streerog and Prasutitantra Department |
| Affiliation |
Tilak Ayurved Mahavidyalay, Pune |
| Address |
Tilak Ayurved Mahavidyalaya
1st floor Streerog and Prasutitantra Department
Rasta peth ,Pune 411011
Pune
MAHARASHTRA
410011
India |
| Phone |
9225632451 |
| Fax |
|
| Email |
dr.musale@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Musale |
| Designation |
Asso. Professor Streerog and Prasutitantra Department |
| Affiliation |
Tilak Ayurved Mahavidyalay, Pune |
| Address |
Tilak Ayurved Mahavidyalaya
1st floor Streerog and Prasutitantra Department
Rasta peth ,Pune 411011
MAHARASHTRA
410011
India |
| Phone |
9225632451 |
| Fax |
|
| Email |
dr.musale@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Tarachand Ayurved Hospital Rasta Peth Pune 411011 |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalay, Pune |
| Address |
Tilak Ayurved Mahavidyalay,
1st floor, Streerog and Prasutitantra Dept, Rasta Peth, Pune 411011 |
| Type of Sponsor |
Private medical college |
|
|
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 Pratiksha Sanjay Ghavate |
Seth Tarachand Ramnath Ayurvedic Hospital Pune |
OPD no 11 Streerog prasutitantra department Seth tarachand hospital Rasta peth, Pune 411011
Pune
MAHARASHTRA |
7066792323
pratikshaghavate2323@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethica Committee , TAMV Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O00-O9A||Pregnancy, childbirth and the puerperium. 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 churna, Reference: Gadnigraha vandhyadhikar 8/11, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 8 Days, anupAna/sahapAna: Yes(details: Ksheer), Additional Information: Anupan- Cow milk |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Married women between the age group 20 – 35 years
Primary and secondary infertility having anovulatory cycles
Anovulatory cycle due to PCOS |
|
| ExclusionCriteria |
| Details |
Participants having Endometriosis, Tubal blockage, Premature ovarian failure, Uterine
fibroids
Known cases of TB, DM, hyperthyroidism
Serology positive participants ( STDs, HIV, HBsAg ).
Congenital anomalies of reproductive organs.
Benign and malignant tumor of reproductive organ.
Menorrhagia, Metrorrhagia, DUB , Hypothyroidism & Hyperprolactinemia |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Ovulation Monitoring on the basis of Endometrial thickness
Conception |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ovulation Monitoring ( follicular study & endometrial thickness)
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
10/11/2024 |
| 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 study will be conducted as a single arm study to evaluate efficacy of dhatryadi yoga in the management of Vandhyatva due to anovulatory cycle . The study will be conducted on age group of 20-35 yrs of females. The duration for the study will be 3 months for each individual. It provide the information regarding dhatryadi yog efficacy for the vandhyatva due to anovulatory cycle. |