| CTRI Number |
CTRI/2025/02/080788 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate the efficacy of Dhatkyadi tail and Kasishadi churna in the management of yoni srava W.S.R. to Abnormal Vaginal Discharge |
|
Scientific Title of Study
|
A Clinical study to evaluate the efficacy of Dhatkyadi tail and Kasishadi churna in the management of yoni srava W.S.R to Abnormal Vaginal Discharge |
| 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 Swati Kumari |
| Designation |
Post graduate scholar |
| Affiliation |
Government Ayurvedic College and Hospital Patna |
| Address |
Department of prasuti tantra evum stri roga Government Ayurvedic College and Hospital kadamkuan budh murti patna bihar 800003
Patna
BIHAR
800003
India |
| Phone |
7482837111 |
| Fax |
|
| Email |
swatikumari201765@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prabha Kumari |
| Designation |
Associate professor and Head of department |
| Affiliation |
Government Ayurvedic College and Hospital |
| Address |
Department of prasuti tantra evum stri roga Government Ayurvedic College and Hospital kadamkuan budh murti patna bihar 800003
Patna
BIHAR
800003
India |
| Phone |
7004860634 |
| Fax |
|
| Email |
dr.prabhapandey@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Kumari |
| Designation |
Post graduate scholar |
| Affiliation |
Government Ayurvedic College and Hospital |
| Address |
Department of prasuti tantra evum stri roga Government Ayurvedic College and Hospital kadamkuan budh murti patna bihar 800003
Patna
BIHAR
800003
India |
| Phone |
7482837111 |
| Fax |
|
| Email |
swatikumari201765@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital, kadamkuan patna Bihar 800003 |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College and Hospital Patna |
| Address |
Government Ayurvedic College and Hospital kadamkuan budh murti patna bihar 800003 |
| Type of Sponsor |
Other [Government Ayurvedic College and Hospital Patna ] |
|
|
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 Prabha Kumari |
Government Ayurvedic College and Hospital Patna |
Prasuti tantra evum Stri roga department OPD room no 01 Government ayurvedic College and Hospital kadamkuan budh murti patna bihar 800003
Patna
BIHAR |
7004860634
dr.prabhapandey@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical 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 | Classical | | (1) Medicine Name: Kasisadi churna, Reference: Acharya Vagbhata, Astangahrdayam, Uttar Sthana 34/51-53, 55, Hindi Commentary by Kaviraja Atrideva Gupta, Chaukhambha Prakashan, Varanasi, Edition, 2015 p. 783., Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -honey), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Dhatkyadi tail, Reference: Acharya Vagbhata, Astangahrdayam, Uttar Sthana 34/51-53, 55, Hindi Commentary by Kaviraja Atrideva Gupta, Chaukhambha Prakashan, Varanasi, Edition, 2015 p. 783., Route: Vaginal, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.Patient willing for trail and agrees to
participate and signs informed consent
2.Age between 18 to 50 yr.
3.Patient complaining of Yoni srava per vagina as a
cardinal symptom.
4. Married women. |
|
| ExclusionCriteria |
| Details |
1.Unmarried women
2.Below 18 yr and above 50 yr
3.Pregnant women & lactating women.
4.Patients suffering from tuberculosis, sexually
transmitted dz. Like VDRL, HIV, syphilis,
Herpes Genitalis, gonorrhea, genital malignancy
and congenital any other pathologies of
reproductive tract."
5.Patients suffering from systemic dz. like HTN,
Diabetes, Heart diseases.
6.Patients suffering from uterine prolapse. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Determination of effect of intervention |
2 months(8weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Determination of effect of intervention w.r.t other |
2 months (8weeks) |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/02/2025 |
| 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="0"
Months="10"
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 - NO
|
|
Brief Summary
|
The cases of yoni srava is increasing day by day.In Ayurveda there are many classical formulations present for yoni srava(abnormal vaginal discharge ) but due to easy availability and good efficiency of my formulation Dhatkyadi tail and Kasishadi churna.l have chosen this topic ’A Clinical Study to evaluate the efficacy of Dhatkyadi tail and Kasishadi churna in the management of yoni srava w.r.t. abnormal vaginal discharge’ |