| CTRI Number |
CTRI/2023/06/053378 [Registered on: 01/06/2023] Trial Registered Prospectively |
| Last Modified On: |
31/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the efficacy of leuc capsule in leucorrhoea |
|
Scientific Title of Study
|
SINGLE ARMED CLINICAL STUDY TO EVALUATED EFFICACY OF LEUC CAPSULE IN LEUCORRHOEA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| JSAM/IECHR/147/04-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaishali Dave |
| Designation |
Associate professor |
| Affiliation |
JS Ayurveda Mahavidyalaya |
| Address |
Department of Prasutitatra JS Ayurved Mahavidyalay
College road , yogiraj society
Kheda
GUJARAT
387001
India |
| Phone |
09662140078 |
| Fax |
|
| Email |
vaishalivasavda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vaishali Dave |
| Designation |
Associate professor |
| Affiliation |
JS Ayurveda Mahavidyalaya |
| Address |
Department of Prasutitantra evam striroga JS Ayurved Mahavidyalay
College road , yogiraj society
Kheda
GUJARAT
387001
India |
| Phone |
09662140078 |
| Fax |
|
| Email |
vaishalivasavda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vaishali Dave |
| Designation |
Assistant professor |
| Affiliation |
JS Ayurveda Mahavidyalaya |
| Address |
Prasuti tantra and Striroga department JS Ayurved Mahavidyalay
College road , yogiraj society
Kheda
GUJARAT
387001
India |
| Phone |
09662140078 |
| Fax |
|
| Email |
vaishalivasavda@gmail.com |
|
|
Source of Monetary or Material Support
|
| “PUNARVASUâ€
Near, Santram Deri Gate,
Petlad Road,
Nadiad – 387002 |
|
|
Primary Sponsor
|
| Name |
PUNARVASU PHARMACY |
| Address |
“PUNARVASUâ€
Near, Santram Deri Gate,
Petlad Road,
Nadiad – 387002 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 |
| DrVaishali Dave |
JS Ayurveda Mahavidyalaya |
OPD no 132, PD patel Ayurveda hospital and JS Ayurved Mahavidyalay
College road , yogiraj society
Kheda
GUJARAT |
09662140078
9662140078
vaishalivasavda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N899||Noninflammatory disorder of vagina, unspecified. Ayurveda Condition: YONIROGAH/YONI-VYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: LEUC CAPSULE, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 3(NA), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: Koshna Jala), Additional Information: -- |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Patients having any complaint of discharge per vagina, Itching sensation at vulva, Burning sensation in vagina, Pain in vagina, Foul smell from vagina , backache and pelvic pain. |
|
| ExclusionCriteria |
| Details |
Female patients having pregnancy, breast feeding or post-delivery period.
Patients with any reproductive tract malignancy.
Patients with other systemic illness.
Patients with positive history of venereal diseases
Patients who are using CU-T or chemical method of contraception.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| white discharge from vagina will reduce |
at 4 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| no reoccurrence of white discharge |
6 weeks |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
14/06/2023 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
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 - Anyone
- 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 - Proposals should be directed to [vaishalivasavda@gmail.com].
- For how long will this data be available start date provided 01-01-2023 and end date provided 12-01-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Leucorrhoea or white discharge is a complaint with which each woman suffers at least once in a lifetime. It refers to the white or yellowish discharge from the vaginal canal. The symptoms of swetapradara either physiological or pathological results into great discomfort and deep agony in the individuals1 Leucorrhoea is found significantly more in married females as compared to unmarried, pregnant as compared to non-pregnant, and women of lower socioeconomic status with high parity.2Symptoms of Leucorrhoea are somewhat similar to Shwetapradara mentioned in Ayurvedic literature but there is no separate chapter given in Brihatrayee. Commentator Chakrapani has explained the word Pandura-Asrigdara as Shwetapradara in his commentary.3Taking into account the side effects and adverse effects of contemporary management , The Ayurvedic management can be recommended as a safer, feasible and effective therapy for the management of leucorrhea. In this study, Ayurveda management by LEUC CAPSULE (combination of Extract of Ashwagandha, Lodhra, Udumber, Guduchi, Vruddhadaru ; Kukutanda twak bhasma, Godanti bhasma, sharkara ) will be carried out to evaluate the efficacy in leucorrhoea. |