| CTRI Number |
CTRI/2024/06/069076 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
16/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Participant will be treated with Ayurvedic intervention Dhatakyadi varti(Suppository)and Pippalyadi varti(Suppository) for the reduction of white discharge per vagina. |
|
Scientific Title of Study
|
Comparative clinical study on the effectiveness of Dhatakyadi and Pippalyadi Yoni Varti in the management of Kaphaja Yoni Vyapad (Vulvo-Vaginitis) |
| 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 Sumedha Yadav |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,B.M Road, Thanniruhalla,Hassan |
| Address |
Department of Prasuti Tantra and Stree Roga,Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,B.M Road, Thanniruhalla,Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
7015543795 |
| Fax |
|
| Email |
sumedhayadav77512@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhu M |
| Designation |
Associate Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,B.M Road, Thanniruhalla,Hassan |
| Address |
Department of Prasuti Tantra and Stree Roga,Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,B.M Road, Thanniruhalla,Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
8970167939 |
| Fax |
|
| Email |
drmadhuayu@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumedha Yadav |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,B.M Road, Thanniruhalla,Hassan |
| Address |
Department of Prasuti Tantra and Stree Roga,Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,B.M Road, Thanniruhalla,Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
7015543795 |
| Fax |
|
| Email |
sumedhayadav77512@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,B.M Road, Thanniruhalla,Hassan, Karnataka,India Phone No-08172256460,E-mail-sdmcah@gmail.com |
|
|
Primary Sponsor
|
| Name |
DrSumedha Yadav |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,B.M Road, Thanniruhalla,Hassan,pin-573201, Karnataka,India |
| Type of Sponsor |
Other [Self] |
|
|
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 Sumedha Yadav |
Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital |
Sri Dharmasthala Manjunatheshwara college of ayurveda and hospital,BM Road,Thanniruhalla ,Hassan,573201,Karnataka
Hassan
KARNATAKA |
7015543795
sumedhayadav77512@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE SRI DHARMASTHALA MANJUNATHESHWARA COLLEGE OF AYURVEDA AND HOSPITAL HASSAN |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N768||Other specified inflammation of vagina and vulva. Ayurveda Condition: KAPAJA-YONIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dhatakyadi Varti, Reference: Charaka Samhita 30/76-79, Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 3(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Yoni prakshalana with sukhoshna jala | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Pippalyadi Varti, Reference: Charaka Samhita 30/70, Route: Vaginal, Dosage Form: Varti/ Suppository, Dose: 3(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Yoni prakshalana with sukhoshna jala |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1.Subject full filling diagnostic criteria and have local signs and symptoms of kaphaja yonivyapad as described in texts such as shweta and picchilasrava,yoni kandu,alpa vedana
2. Married women of 21-50 years
3. Patient willing to sign informed written consent form. |
|
| ExclusionCriteria |
| Details |
1.Pregnant women
2.Lactating women
3.Diagnosed case of Cervical Pathology like carcinoma of cervix,polyps.
4.Subjects positive for HIV,VDRL,HBsAg
5.Known case of Diabetes mellitus,pelvic inflammatory disease
6.Post menopausal women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Major symptoms like curdy white discharge ,vulval and vaginal itching should be cured |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Other symptoms like backache, pain during coitus should be cured. |
15 days |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
01/07/2024 |
| 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
|
This study is open labeled double arm clinical trial to evaluate the effect of Dhatakyadi Varti and Pippalyadi Varti in 32 patients with kaphaja yonivyapad (vulvo-vaginitis). The study will be conducted at in/out patient in department of prasuti tantra and stree roga in Sri Dharmasthala Manjunatheshwara ayurveda hospital,hassan,Karnataka.Group A 16 Patients will be administered with 500ml sukhoshana jala for yoni prakshalana and three gram Dhatakyadi Yoni varti for one yama or till amutra kala once a day for 7 days and in Group B 16 Patients will be administered with 500ml sukhoshana jala for yoni prakshalana and three gram Pippalyadi Yoni varti for one yama or till amutra kala once a day for 7 days. |