CTRI

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CTRI Number

CTRI/2025/04/084188 [Registered on: 04/04/2025] Trial Registered Prospectively

Last Modified On:

17/03/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

A STUDY TO EVALUVATE THE EFFICACY OF SARALADI CHURNA YONI DHUPAN AND LODHRADI KASAYA YONI DHAVAN IN SHWETAPRADARA

Scientific Title of Study

A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF SARALADI CHURNA YONI DHUPAN AND LODHRADI KASAYA YONI DHAVAN IN SHWETAPRADARA W.S.R TO LEUCORRHOEA

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 VIBHUTI DESHMUKH
Designation	PG SCHOLAR
Affiliation	MANSAROVAR AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE , BHOPAL
Address	DEPARTMENT OF PRASUTI TANTRA EVUM STRI ROGA, THIRD FLOOR, MANSAROVAR AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, KOLAR ROAD, BHOPAL Bhopal MADHYA PRADESH 462042 India
Phone	7999121394
Fax
Email	vibhutideshmukh16@gmail.com

Details of Contact Person
Scientific Query

Name	DR CHANDRAPRABHA PINGE
Designation	ASSOCIATE PROFESSOR
Affiliation	MANSAROVAR AYURVEDIC MEDICALD COLLEGE HOSPITA L AND RESEARCH CENTRE, BHOPAL
Address	DEPARTMENT OF PRASUTI TANTRA EVUM STRI ROGA, THIRD FLOOR MANSAROVAR AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, KOLAR ROAD, BHOPAL Bhopal MADHYA PRADESH 462042 India
Phone	9420248023
Fax
Email	drchandraprabha0611@gmail.com

Details of Contact Person
Public Query

Name	DR CHANDRAPRABHA PINGE
Designation	ASSOCIATE PROFESSOR
Affiliation	MANSAROVAR AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, KOLAR ROAD, BHOPAL
Address	DEPARTMENT OF PRASUTI TANTRA EVUM STRI ROGA, THIRD FLOOR, MANSAROVAR AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, KOLAR ROAD, BHOPAL Bhopal MADHYA PRADESH 462042 India
Phone	9420248023
Fax
Email	drchandraprabha0611@gmail.com

Source of Monetary or Material Support

MANSAROVAR AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER,KOLAR ROAD, BHOPAL

Primary Sponsor

Name	MANSAROVAR AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE
Address	DEPARTMENT OF PRASUTI TANTRA EVUM STRI ROGA, THIRD FLOOR MANSAROVAR AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, BHOPAL
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
DR VIBHUTI DESHMUKH	MANSAROVAR AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, BHOPAL	DEPARTMENT OF PRASUTI TANTRA EVUM STRI ROGA, THRID FLOOR, MANSAROVAR AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE, BHOPAL Bhopal MADHYA PRADESH	7999121394 vibhutideshmukh16@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
MANSAROVAR AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER, BHOPAL	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:N889\|\|Noninflammatory disorder of cervixuteri, unspecified. Ayurveda Condition: KAPAJA-YONIROGAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Comparator Arm	Procedure	-	dhUpana, धूपन	(Procedure Reference: CHARAKA SAMHITA, Procedure details: SARALADI CHURNA YONI DHUPANA 5 MINT/DAY 7 DAYS) (1) Medicine Name: SARALADI, Reference: CHARAKA SAMHITA, Route: Vaginal, Dosage Form: Churna/ Powder, Dose: 15(g), Frequency: od, Duration: 7 Days
2	Intervention Arm	Procedure	-	yoni dhAvana, योनि धावन	(Procedure Reference: CHARAKA SAMHITA, Procedure details: LODHRADI KWATHA YONI DHAVANA 5MINT/DAY 7 DAYS) (1) Medicine Name: LODHRADI, Reference: CHARAKA SAMHITA, Route: Vaginal, Dosage Form: Kwatha/Kashaya, Dose: 800(ml), Frequency: od, Duration: 7 Days

Inclusion Criteria

Age From	18.00 Year(s)
Age To	45.00 Year(s)
Gender	Female
Details	THE PATIENT HAVING CLASSICAL SYMPTOMS OF SHWETAPRADARA AS PER THE CLASSICAL REFERENCES WILL BE SELECTED

ExclusionCriteria

Details

PREGNANT WOMEN. PATIENT SUFFERING FROM OTHER GENITAL TRACT DISEASES GONORRHEA,GENITAL HERPES,DM,CERVICAL EROSION,CARCINOMA ETC. PATIENT DURING MENSTRUATION WILL BE EXCLUDED.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
WHITISH DISCHARGE FROM THE VAGINA,FOUL SMELL	120 days

Secondary Outcome

Outcome	TimePoints
CBC URINE R,M	120 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 2/ Phase 3

Date of First Enrollment (India)

10/05/2025

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)

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 - NO

Brief Summary

SHWETAPRADARA AS THE MAJOR COMPLAINT WHICH IF NEGLECTED MAY LEAD TO ASCENDING INFECTION HARMING THE GENRAL HEALTH AND DISTURBING THE WOMEN PSYCHOLOGICALLY. AS MANY AS ONE-THIRD OF WOMEN WILL HAVE IT DURING THEIR LIFE TIME.A VAGINAL DISCHARGE IS PRESENT IN 70-80% OF WOMEN WORLDWIDE. PREVALENCE RATE OF LEUCORRHEA IS 28.99 WORLDWIDE. AS STATED BY WHO HAS ESTIMATION AS MANY AS 357 MILLION NEW CASES OF WOMEN AGED BETWEEN 18-45 YEARS WERE REPORTED. THE TREATMENT AVAILABLE IS SYMPTOMATIC AND CAUSES RECURRENCE,SO WITH THE HELP OF AYUVEDA WE CAN GIVE A GOOD RESULT IN SHWETAPRADARA. SO THE SARALADI CHURNA YONI DHUPAN AND LODHRADI KASAYA YONI DHAVAN HAS BEEN SELECTED TO STUDY THE EFFICACY OF BOTH PROCEDURE IN SHWETAPRADARA.