| CTRI Number |
CTRI/2025/09/094620 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between Garbhaprada Yoga With And Without Naryana Taila Uttar Basti In Infertility |
|
Scientific Title of Study
|
Comparative Clinical Evaluation Of Garbhaprada Yoga With And Without Naryana Taila Uttar Basti On Ovulatory Factor In Infertility |
| 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 Anjali Verma |
| Designation |
Assistant Professor |
| Affiliation |
Rishikul Campus Haridwar |
| Address |
PG Department of Prasuti Tantra Evum Stree Roga, Rishikul Campus, Haridwar, Uttarakhand Ayurved University
Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
6398967773 |
| Fax |
|
| Email |
drvermaanjali@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjali Verma |
| Designation |
Assistant Professor |
| Affiliation |
Rishikul Campus Haridwar |
| Address |
PG Department of Prasuti Tantra Evum Stree Roga, Rishikul Campus, Haridwar, Uttarakhand Ayurved University
Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
6398967773 |
| Fax |
|
| Email |
drvermaanjali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manju Devi |
| Designation |
Post Graduation Scholar |
| Affiliation |
Rishikul Campus Haridwar |
| Address |
PG Department of Prasuti Tantra Evum Stree Roga, Rishikul Campus, Haridwar, Uttarakhand Ayurved University
Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
07889685583 |
| Fax |
|
| Email |
yeshman27@gmail.com |
|
|
Source of Monetary or Material Support
|
| PG Department Of Prasuti Tantra Evum Stree Roga OPD No 9 Rishikul Campus Haridwar Devpura 249401 Uttarakhand Ayurved University Uttarakhand India |
|
|
Primary Sponsor
|
| Name |
Rishikul Campus Haridwar |
| Address |
Rishikul Campus Haridwar Uttarakhand Ayurved University OPD No 9 Devpura Haridwar 249401 Uttarakhand India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 MANJU DEVI |
RISHIKUL CAMPUS HARIDWAR |
OPD No 9 PG Department of Prasuti Tantra Evum Stree Roga Uttarakhand Ayurved University
Haridwar
Uttarakhand
249401
India
Hardwar
UTTARANCHAL |
07889685583
yeshman27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Uttarakhand Ayurved University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N979||Female infertility, unspecified. Ayurveda Condition: VANDHYA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Garbhaprada Yoga, Reference: Yogaratnakar Uttardh Chapter 45 Verse 5 , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Madhu Ksheer Ghrita ), Additional Information: - | | 2 | Comparator Arm | Procedure | - | uttara-bastiH, उत्तर-बस्तिः | (Procedure Reference: Kashyap Samhita Sidhi Sthana Chapter 7 Verse 11, Procedure details: Patient Adviced To Empty The Bladder And Lie In Lithotomy Position Aseptic Precautions Will Be Adopted During Procedure Cuscos Approximation Will Be Performed For Proper Visualisation Of Cervical External Os And Utrerine Sound Will Be Passed Through External Os To Find The Position Of Uterus Then The 5ml Medicated Oil Will Be Pushed Slowly With The Help Of IUI Cannula Fitted With Disposable Syringe And Then The Patient Will Be Kept In Head Low Position The Procedure Done For 6 Days For 2 Consecutive Cycle Total Of 12 Days)
(1) Medicine Name: Narayana Taila , Reference: Sharangdhar Samhita Chapter 9 Verse 109, Route: Vaginal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 12 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Married female patient age (20-40years) having infertility.
Primary and Secondary both types of female infertility due to ovulatory factor defect
|
|
| ExclusionCriteria |
| Details |
Patent having pelvic disease such as PID, Fibroids, and Ovarian Cyst(more than 3cm)
Patient having Gross Congenital Deformities of reproductive tract i.e. uterus, cervix, vagina
Patient having any debilitating disorders like T.B, Anemia (Hb percent less than 8 gm per dl), Jaundice, Hypertension, Diabetes Mellitus, Thyroid dysfunction, Renal disorders, Cardiac Disease, Malignancies, STDs etc.
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correction Of Ovulatory Defect |
2 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Conception |
2 Months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
26/09/2025 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 10-09-2026 and end date provided 02-01-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
PREVIOUS
AYURVEDA RESEARCHES INDIVIDUALLY PROVEN THAT THERE IS SIGNIFICANT EFFECT
OF GARBHAPRADA YOGA (BY THE NAME BALADI CHURNA)
AND NARAYANA TAILA (IN FORM OF UTTAR BASTI, NASYA AND MATRA
BASTI) ON OVULATION IN FEMALE INFERTILITY. UTTAR BASTI IS
A UNIQUE PROCEDURE, TO ADMINISTER DRUG DIRECTLY INTO UTERUS TO PROVIDE BEST
POSSIBLE THERAPEUTIC DOSE ON AFFECTED SITE. THIS STUDY IS A COMPARATIVE CLINICAL EVALUATION OF GARBHAPRADA YOGA WITH AND WITHOUT NARAYANA TAILA UTTARBASTI ON OVULATORY FACTOR IN INFERTILITY 20 PATIENTS WILL BE TAKEN IN EACH GROUP A NARAYANA TAILA UTTARBASTI AND GARBHAPRADA YOGA CURNA ORALLY WILL BE GIVEN TO GROUP A AND GARBHAPRADA YOGA ORALLY WILL BE GIVEN TO GROUP B UTTARBASTI OF 5ML NARAYANA TAIL IN ONE SITTING FOR 6 DAYS AND GARBHAPRADA YOGA 5GM FOR TWICE DAILY FOR 2 MONTHS |