| CTRI Number |
CTRI/2026/03/106822 [Registered on: 24/03/2026] Trial Registered Prospectively |
| Last Modified On: |
24/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Clinical Study on the Efficacy of Udumbaradi Taila and Guduchidantyadi Malhar in the Management of Acharana Yonivyapad (Pruritus Vulvae) |
|
Scientific Title of Study
|
Comparative clinical study to evaluate the efficacy of Udumbaradi Taila with Guduchidantyadi Malhar in the management of Acharana Yonivyapad with special reference to Pruritus Vulvae. |
| 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 Akanksha Shukla |
| Designation |
PG Scholar |
| Affiliation |
Chandra Shekhar Singh Ayurvedic Sansthan |
| Address |
Department of Prasuti Tantra
Kaushambi
UTTAR PRADESH
212213
India |
| Phone |
639344955 |
| Fax |
|
| Email |
dr.akanksha955@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akanksha Shukla |
| Designation |
PG SCHOLAR |
| Affiliation |
Chandra Shekhar Singh Ayurvedic Sansthan |
| Address |
Department of Prasuti Tantra
Kaushambi
UTTAR PRADESH
212213
India |
| Phone |
639344955 |
| Fax |
|
| Email |
dr.akanksha955@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PROF DR MAYANK KESHARWANEE |
| Designation |
PROFESSOR |
| Affiliation |
Chandra Shekhar Singh Ayurvedic Sansthan |
| Address |
Department of Prasuti Tantra
Kaushambi
UTTAR PRADESH
212213
India |
| Phone |
7376383840 |
| Fax |
|
| Email |
mayankkesharwani9@gmail.com |
|
|
Source of Monetary or Material Support
|
| CHANDRA SHEKHAR SINGH AYURVED Chikitsalaya evam Shod Kendra, KOILAHA, KAUSHAMBI (U.P.)212213 INDIA |
|
|
Primary Sponsor
|
| Name |
Chandra Shekhar Singh Ayurved Chikitsalaya evam Shodh Kedra |
| Address |
Koilaha, Kaushambi (U.P.) 212213 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 Akanksha Shukla |
Chandra Shekhar Singh Ayurvedic Chikitsalaya evam shodh kendra |
OPD No 105, Prasuti Tantra evam Stri Rog
Kaushambi
UTTAR PRADESH |
6393440955
dr.akanksha955@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe CSSAS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N908||Other specified noninflammatory disorders of vulva and perineum. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Udumbaradi Taila, Reference: Bhaishajya Ratnavali, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Applied locally over vulval region after proper cleaning twice daily for 30 days. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Guduchidantyadi Malhar, Reference: Bhaishajya Ratnavali, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Applied locally over vulval region after proper cleaning twice daily for 30 days for comparative evaluation. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Adult female who are in age group of 18-45 years.
Only married patient.
Patients having pruritus vulvae as a cardinal symptom with or without vaginal discharge |
|
| ExclusionCriteria |
| Details |
Patients below 18yrs and above 45yrs.
Patient unwilling to participate in trial.
Patients after menopause.
Patient of uterine prolapse &Carcinoma.
Patient on oral contraceptives, or using intrauterine contraceptive devices.
Patients with diabetes mellitus, tuberculosis, jaundice, severe HTN.
Patients with extensive chronic cervicitis, fibroid and malignancy.
VDRL, HIV, HBsAg ,HCV positive patient. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in Yoni Kandu (itching) |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Yoni srava
Daurgandhya
Vedana
Dyspareunia
Vaginal pH |
90 days |
|
|
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 1 |
|
Date of First Enrollment (India)
|
06/04/2026 |
| 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="3"
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 - 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
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.akanksha955@gmail.com].
- For how long will this data be available start date provided 20-03-2026 and end date provided 19-05-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NA
|
|
Brief Summary
|
Acharana Yonivyapad is a gynecological disorder described in Ayurveda, mainly caused due to improper genital hygiene, leading to symptoms like itching (kandu) in the vulval region. It is clinically correlated with Pruritus Vulvae, which is commonly associated with vaginal discharge, burning sensation, dyspareunia and discomfort. Conventional treatments such as antibiotics and antifungals may cause side effects and disturb normal vaginal flora.
The present study is a randomized comparative clinical trial to evaluate the efficacy of Udumbaradi Taila Yoni Pichu and Guduchidantyadi Malhar in the management of Acharana Yonivyapad. A total of 60 patients will be randomly divided into two groups. Group A will receive Udumbaradi Taila Yoni Pichu and Group B will receive Guduchidantyadi Malhar for local application, for 7 days after cessation of menstruation for 3 consecutive cycles.
The outcome will be assessed based on improvement in symptoms like itching, vaginal discharge, malodour, pain, dyspareunia and vaginal pH. This study aims to evaluate a safe, effective and cost-efficient Ayurvedic management for Pruritus Vulvae. |