| CTRI Number |
CTRI/2023/05/053262 [Registered on: 30/05/2023] Trial Registered Prospectively |
| Last Modified On: |
29/05/2023 |
| 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
|
Study of Phala Ghrit on Beejotsarga and its efficacy on Infertility due to Ovarian factor |
|
Scientific Title of Study
|
EFFECT OF PHALA GHRITA ON DEVELOPMENT OF OVARIAN FOLLICLE FOLLOWED BY BEEJOTSARGA (OVULATION) IN PATIENTS OF INFERTILITY DUE TO OVARIAN FACTOR IN COMPARISON WITH CLOMIPHENE CITRATE |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohan Ramchandra Yende |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of Rachana Shareer,
Mahatma Gandhi Ayurved College, Hospital and Research Center, Salod Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9970137300 |
| Fax |
|
| Email |
yrmohan1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pradnya Dandekar |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of Kriya Shareer
Mahatma Gandhi Ayurved College Hospital and Research Center Salod Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
940338656 |
| Fax |
|
| Email |
pradnya.dandekar@dmimsu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohan Ramchandra Yende |
| Designation |
Professor |
| Affiliation |
|
| Address |
Department of Rachana Shareer,
Mahatma Gandhi Ayurved College, Hospital and Research Center, Salod Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9970137300 |
| Fax |
|
| Email |
yrmohan1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patients will be recruited from IPD and OPD of MGAC & RH Salod Wardha |
|
|
Primary Sponsor
|
| Name |
MOHAN YENDE |
| Address |
301, MEERA MOHAN VILLA , 11 OLD SUBHEDAR LAY OUT, NAGPUR 440024 |
| Type of Sponsor |
Other [self] |
|
|
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 Mohan Yende |
Jawaharlal Nehru Medical College , Sawangi |
Department of Gynecology and Obs. Sawangi Di. Wardha
Wardha
MAHARASHTRA |
9970137300
yrmohan1@gmail.com |
| Dr Mohan Yende |
Mahatma Gandhi Ayurveda College and Research Hospital |
Department of Stree Roga and Prasuti tantra, Salod, Di Wardha
Wardha
MAHARASHTRA |
9970137300
yrmohan1@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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Phala Ghrita |
Route - Oral
Dose - 10 ml B.D.
Anupana – Cow milk 100 ml
|
| Comparator Agent |
Tab Clomiphene citrate |
Route - Oral
Dose – 50 mg O.D. for 5 days from day 3 to 7 of Menstrual cycle 42,43
Anupana – Plane Water
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Married females unable to conceive from 1 year of active married life
2. Patients with primary or secondary Infertility due to ovarian factors
3. Irregular or scanty menses due to anovulatory cycle
4. Anovulatory cycle
5. Unruptured ovarian follicle
|
|
| ExclusionCriteria |
| Details |
1. Unmarried and non-fertile age group patients
2. Infertility other than ovarian causes e.g. cervical, uterine causes.
3. Cervical tumor, polyp, Ca cervix, Uterine fibroid
4. Congenital anomalies in female genital tract
5. Tubercular endometritis, Malignant and cytotoxic patients
6. HIV/VDRL/HbsAg positive
7. Non-Cooperative and patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Beejotsarga (Ovulation) |
Cycle 1 TVS from day 10
Cycle 2 TVS from day 10
Cycle 3 TVS from day 10 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Conception |
after 28 day of cycle |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
19/06/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Failure to ovulate is the major problem in India approximately 30% - 40% cases of female infertility. The Beeja is the core stone of the female reproductive process and absence of this factor Garbha cannot occur in spite of the proper Ritu, Kshetra and Ambu. Vagbhat stated the effect of Phalaghrita on Vandhyatva(infertility), so with an objective to study the effect of Phalaghruta in comparison with clomiphene citrate study will be carried out. Materials and methods-This Single blind(participant) randomized control clinical involves two groups with 30 subjects each. Group A (Study Group)will be treated with administration of Phala Ghritain the dose of 10 ml B.D. orally with Anupana of cow milk 100 ml. Group B(Control Group)will be treated with administration of Tab. Clomiphene citrate50 mg O.D. orally for 5 days from day 3 to 7 of Menstrual cycle. Expected outcome - Primary outcome of study will be development of follicle and Beejotsarga (ovulation) and Secondary outcome will be conception. Conclusion- Effect of drug Phala Ghrita will be stated as per observed result. |