| CTRI Number |
CTRI/2026/02/103112 [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
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to see the effects of Saubhagyanandan ghrita and Balaadi churna in improving uterine health in women with infertility |
|
Scientific Title of Study
|
A SINGLE ARM CLINICAL TRIAL TO EVALUATE THE EFFICACY OF SAUBHAGYANANDAN GHRITA AND BALAADI CHURNA ON VANDHYATVA W.S.R TO ENDOMETRIAL RECEPTIVITY |
| 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 Priyanka Carpenter |
| Designation |
MS Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Department of Prasuti Tantra evam Stree Rog,
National Institute of Ayurveda
Jorawarsingh Gate,Amer Road
Jaipur
National Institute of Ayurveda
Jaipur
RAJASTHAN
302002
India |
| Phone |
7089188669 |
| Fax |
|
| Email |
dr.priyanka_sharma@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr B Pushpalatha |
| Designation |
MD(Ayu.) PhD ( Ayu).,Professor |
| Affiliation |
National Institute Of Ayurveda |
| Address |
3rd floor,Department of Prasuti Tantra evum Stree Rog,
National Institute of Ayurveda
Jorawar singh gate,Amer Road
Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9413206790 |
| Fax |
|
| Email |
pushpalathania@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr B Pushpalatha |
| Designation |
MD(Ayu.) PhD ( Ayu).,Professor |
| Affiliation |
National Institute Of Ayurveda |
| Address |
3rd floor,Department of Prasuti Tantra evum Stree Rog,
National Institute of Ayurveda
Jorawar singh gate,Amer Road
Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9413206790 |
| Fax |
|
| Email |
pushpalathania@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda
Jorawarsingh Gate,Amer Road
Jaipur.Rajasthan.PIN 302002
India |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
National Institute of ayurveda
Jorawarsingh Gate ,Amer Road
Jaipur,Rajasthan
PIN 302002
India |
| Type of Sponsor |
Government 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 PRIYANKA CARPENTER |
National Institute of Ayurveda ,Jaipur ,Rajasthan |
OPD and IPD settings Department of prasuti tantra evam stree rog,
National Institute of Ayurveda
Jorawar singh Gate,Amer Road
Jaipur
Jaipur
RAJASTHAN |
07089188669
dr.priyanka_sharma@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, NATIONAL INSTITUTE OF AYURVEDA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N972||Female infertility of uterine origin. Ayurveda Condition: VANDHYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Balaadi churna, Reference: Bhaavprakash Madhyam khand page 770, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Suabhagyanandana Ghrita, Reference: Saubhagyanadana Ghrita is mentioned in Abhinava Navjeevana text by Prof. Siddhinandana Mishra in Vandhya Chikitsa Adhyaya.[7], Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -milk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Females in the age group 21-40 years, with active married life of minimum 1 year.
2. Patients having primary or secondary infertility with Applebaum’s scoring less than 13.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in endometrial receptivity as per USSR as per Modified Applebaum’s
score.
|
At baseline and after completion of 2 months of treatment
score.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| •Changes in the Basal S. Estradiol( E2) and Progesterone level. |
At baseline and after completion of 2 months of treatment |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/05/2026 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Female infertility is a significant reproductive health problem, and impaired endometrial receptivity is an important contributing factor. In Ayurveda, Vandhyatva is attributed to Dosha imbalance, Dhatu kshaya and dysfunction of Garbhashaya. Saubhagyanandana Ghrita and Balaadi Churna are classical Ayurvedic formulations with Balya, Brimhana and Garbhasthapana properties, which may improve uterine environment and endometrial receptivity.
This single arm clinical trial is designed to evaluate the efficacy of Saubhagyanandana Ghrita and Balaadi Churna in the management of female infertility with special reference to endometrial receptivity. Eligible participants will receive the study drugs for a fixed duration. Outcomes will be assessed using AppleBaum score usind ultrasonographic color doppler evaluation of endometrial thickness and pattern.
|