| CTRI Number |
CTRI/2024/06/069226 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [RANDOMIZED COMPARATIVE STUDY] |
| Study Design |
Other |
|
Public Title of Study
|
Management of stress in Primary Female infertitlity |
|
Scientific Title of Study
|
A Randomized Comparative Clinical
study to evaluate the efficacy of
BrahmiGhrita and KalyanakaGhrita in
the management of Stress in Unexplained
Primary Female Infertility |
| Trial Acronym |
drug |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Seeta MBiradar |
| Designation |
Professor and Head |
| Affiliation |
BLDEASAVSAYURVEDAMAHAVIDYALAYA ,VIJAYAPUR AND SHRI BMPATILMEDICAL COLLEGE VIJAYAPUR KARANATAKA |
| Address |
Dr.Seeta MBiradar , Professor and Head, Dept. of
Roganidanaevum vikrutivijanan, OPD No. 6, BLDEA’s AVS Ayurveda
Mahavidyalayavidya nagar bagalkot road Vijayapura
India
BLDE(Deemed to be university)ShriB M Patil Medical college Vijayapur Karnataka
Bijapur
KARNATAKA
586109
India |
| Phone |
8951695201 |
| Fax |
- |
| Email |
drseetabijapur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seeta MBiradar |
| Designation |
Professor and Head |
| Affiliation |
BLDEASAVSAYURVEDAMAHAVIDYALAYA ,VIJAYAPUR AND SHRI BMPATILMEDICAL COLLEGE VIJAYAPUR KARANATAKA |
| Address |
BLDEAS AVS AYURVEDA MAHAVIDYALAYA VIJAYAPUR KARNATAKA
BLDE(Deemed to be university)ShriB M Patil Medical college Vijayapur Karnataka
Bijapur
KARNATAKA
586109
India |
| Phone |
8951695201 |
| Fax |
- |
| Email |
drseetabijapur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seeta MBiradar |
| Designation |
Professor and Head |
| Affiliation |
BLDEASAVSAYURVEDAMAHAVIDYALAYA ,VIJAYAPUR AND SHRI BMPATILMEDICAL COLLEGE VIJAYAPUR KARANATAKA |
| Address |
BLDEAS AVS AYURVEDA MAHAVIDYALAYA VIJAYAPUR KARNATAKA
BLDE(Deemed to be university)ShriB M Patil Medical college Vijayapur Karnataka
Bijapur
KARNATAKA
586109
India |
| Phone |
918951695201 |
| Fax |
- |
| Email |
drseetabijapur@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLDEUS SHRI B M PATIL MEDICAL COLLEGE |
|
|
Primary Sponsor
|
| Name |
BLDEUS SHRI B M PATIL MEDICAL COLLEGE AND RESEARH CENTRE |
| Address |
SMT BANGARAMMA SAJJANA CAMPUS |
| 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 Seeta MBiradar |
BLDEA’s AVS Ayurveda MahavidyalayaVijayapu r and BLDEUs shri B M PATIL MEDICAL COLLEGE |
Dr Seeta M.Biradar
Prof&Head
Dept.of Roganidana&Vikrutivijnan
BLDEAS AVS AYURVEDA MAHAVIDYALAYA,VIJAYAPUR KARNATAKA
Bijapur
KARNATAKA |
8951695201
-
drseetabijapur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicalCommitteBLDEAVSAyurvedaMahavidyalayaVijayapur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E289||Ovarian dysfunction, unspecified. Ayurveda Condition: VANDYATVA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bhrami ghrita , Reference: Astanga Hridaya Uttarsthana 6/25-26, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: ushnodaka), Additional Information: bhrami ghrita is control drug | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: kalyanaka ghrita, Reference: Astanga Hrudaya Uttarasthana 6/26-28,Shasrayoga, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: ushnodaka), Additional Information: Kalyanaka ghrita is Trial group |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Subjects between age group 21yrs to 35yrs.
• Subjects with stress(mental & physical) .
• Subjects with unexplained infertility.
• Male counterpart should be normal in all aspects .
• Duration of infertility less than 10yrs. |
|
| ExclusionCriteria |
| Details |
Subjects with systemic disorders.
• Subjects with Hypothyroidism &
Hyperthyroidism.
• Tubal blockage. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Parameters of study
Objective and subjective parameters.
Subjective parameter
The Perceived Stress Scale Questionnaire
Hysterosalphingogram (HSG)
Ultrasonographynalysis:
Hormone study-LH
FSH
TSH
CBC
AMH |
every 15days follow up ,after one month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SCREENING OF FEMALE PRIMARY SUBJECTS WILL BE DONE FORM BLDE AVS AYURVEDA MAHAVIDYALAYA ,VIJAYAPUR |
1 Year |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Stress is seen as the cause for the Female infertility in working women and Also in house wives those are pressurized in family life.Seeing this objectives and prevalence rate.The infertility evaluation is typically initiated after 1 year of trying to conceive, but in couples with advanced female age (> 35 years), most practitioners initiate diagnostic evaluation after an inability to conceive for 6 months. The Practice Committee of the American Society for Reproductive Medicine (ASRM) has published guidelines for a standard infertility evaluation. Hence the present study is undertaken to over come the Stress in Unexplained Female Infertility with Medhya Rasayana to see the efficacy of Bramhi ghrita and Kalyanaka ghrita. |