| CTRI Number |
CTRI/2025/10/096637 [Registered on: 30/10/2025] Trial Registered Prospectively |
| Last Modified On: |
06/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical Evaluation of Dhatrayadi Ghrita Uttarbasti and Latakaranja Ghanavati in the Management of Anovulatory Infertility |
|
Scientific Title of Study
|
Efficacy Of Dhatrayadi Ghrita Uttar Basti Combined With Latakaranja Ghanavati Orally In The Management Of Infertility Due To Anovulation An Exploratory Study |
| 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 Ritiksha Jopale |
| Designation |
PG Scholar |
| Affiliation |
All Inddia Institute of Ayurveda |
| Address |
Department of Stri Roga Evam Prasuti Tantra 4th floor Academic Block All India Institute of Ayurveda Mathura road Gautampuri Sarita Vihar Delhi 110076
South
DELHI
110076
India |
| Phone |
09021076122 |
| Fax |
|
| Email |
ritikshaqueen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenakshi Pandey |
| Designation |
Associate Professor |
| Affiliation |
All Inddia Institute of Ayurveda |
| Address |
Department of Stri Roga Evam Prasuti Tantra 4th floor Academic Block All India Institute of Ayurveda Mathura road Gautampuri Sarita Vihar Delhi 110076
South
DELHI
110076
India |
| Phone |
9984549998 |
| Fax |
|
| Email |
drmeenakshipathak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meenakshi Pandey |
| Designation |
Associate Professor |
| Affiliation |
All Inddia Institute of Ayurveda |
| Address |
Department of Stri Roga Evam Prasuti Tantra 4th floor Academic Block All India Institute of Ayurveda Mathura road Gautampuri Sarita Vihar Delhi 110076
South
DELHI
110076
India |
| Phone |
9984549998 |
| Fax |
|
| Email |
drmeenakshipathak@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda Gautampuri New Delhi 110076 |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Ayurveda |
| Address |
405 Seminar Hall Department Of Stri Roga And Prasuti Tantra All India Institute Of Ayurveda Sarita Vihar New Delhi 110076 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 Ritiksha Jopale |
All India Institute of Ayurveda |
Department of Stri Roga Evam Prasuti Tantra 4th floor Academic Block All India Institute of Ayurveda Mathura road Gautampuri Sarita Vihar Delhi 110076
South
DELHI |
9021076122
ritikshaqueen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONALETHICSCOMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N970||Female infertility associated withanovulation. Ayurveda Condition: VANDHYA, (2) ICD-10 Condition:N970||Female infertility associated withanovulation. Ayurveda Condition: VANDH, (3) ICD-10 Condition:N970||Female infertility associated withanovulation. Ayurveda Condition: VANDH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Latakaranja Ghanavati, Reference: Bhava Prakasha Nighantu Guduchyadi Varga, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Days, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: From Day 3 of menses for 12 days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Married Women aged 20 to 35 years in reproductive age group
Diagnosed with anovulatory infertility confirmed by TVS
Regular or irregular cycles with confirmed absence of ovulation
Normal uterine cavity and tubal patency HSG or laparoscopy
Partner with normal semen analysis
Those patients who are eligible for Basti karma
Provided written informed consent
|
|
| ExclusionCriteria |
| Details |
Tubal blockage, uterine anomalies or endometriosis
Uncontrolled endocrine and Metabolic disorders
Acute PID
Severe systemic illness diabetes hypertension hepatic renal disorders Tuberculosis
Concurrent use of other fertility treatments or hormone therapy
Pregnant or lactating women
History of pelvic surgery affecting reproductive organs
Those patients who are not eligible for Basti karma
Patient on Metformin and other insuline sensitizing medication Rosiglitazone Pioglitazone
Patient on Clomiphene citrate or estrogen modulators
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Follicular Development Ovarian Volume and Ovulation Assessed By Transvaginal Sonographic TVS Follicular Monitoring |
Within 2 weeks prior to treatment start and Day 2 3 after menses |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Regularisation of the menstrual cycle Endometrial thickness
Hormonal profile changes
Conception status this secondary outcome |
Each cycle (Cycle 1–3) end of treatment (Week 12) follow-up (Week 24)
(Day 2–3) mid-cycle Day 12–14 of each cycle end of treatment (Week 12) optional follow-up (Week 16–18)
(Day 2–3) optional mid-cycle Cycle 2 (Day 14) post-treatment (Week 12) follow-up (Week 24)
Each treatment cycle end of treatment (Week 12) follow up (Week 24) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/12/2025 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Title of Study
Efficacy of Dhatryadi Ghrita Uttar Basti combined with Latakaranja Ghanavati orally in the management of infertility due to anovulation An exploratory study Background
Anovulation is a major cause of female infertility contributing to about 25 to 30 percent of cases. Modern ovulation induction drugs may have side effects and limited success. Ayurveda offers non hormonal approaches like Uttar Basti and herbal formulations Dhatryadi Ghrita has uterine and hormonal modulatory action while Latakaranja is known for ovulation inducing and endocrine regulating properties Objectives
Primary Objective
To evaluate the effect of Dhatryadi Ghrita Uttar Basti with Latakaranja Ghanavati orally on follicular development ovarian volume and ovulation assessed by transvaginal sonography Secondary Objectives
To assess effect on endometrial thickness hormonal profile menstrual pattern and conception status Study Design
Exploratory prospective single group clinical trial
Sample size 30 women
Duration 3 months with 1 month follow up Intervention
Dhatryadi Ghrita Uttar Basti 5 ml intrauterine for 5 days in 3 consecutive cycles after menstruation
Latakaranja Ghanavati 500 mg twice daily orally for 12 days from day 3 of each cycle for 3 cycles Inclusion Criteria
Married women aged 20 to 35 years diagnosed with anovulatory infertility with normal uterine cavity and tubal patency partner with normal semen analysis Exclusion Criteria
Tubal blockage uterine anomalies endometriosis uncontrolled systemic or endocrine disorders acute pelvic infection severe illness pregnancy or use of other fertility drugs Outcome Measures
Primary Follicular development ovarian volume and ovulation
Secondary Endometrial thickness hormonal profile menstrual regularity and conception Statistical Analysis
Paired T test or Wilcoxon signed rank test for within group changes. Repeated measures ANOVA or Friedman test for multiple observations. Significance level p less than 0.05 Ethical Considerations
Study will be conducted after approval from Institutional Ethics Committee and registered with CTRI. Written informed consent will be taken from all participants |