| CTRI Number |
CTRI/2023/09/057996 [Registered on: 25/09/2023] Trial Registered Prospectively |
| Last Modified On: |
23/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Abnormal Vaginal Discharge by giving Vaginal Wash. |
|
Scientific Title of Study
|
Clinical Study to evaluate the Effectiveness of Raajavrukshadi Kashaya Yoni Prakshalana and Panchakashaya Taila Yoni Pichu in the Management of Kaphaja Yonivyapath. |
| 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 Mariyamma |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan. |
| Address |
OPD-20, Department of Prasuti Tantra and Stri roga Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Thanniruhalla, B.M. Road
Hassan
KARNATAKA
573201
India |
| Phone |
8073429292 |
| Fax |
|
| Email |
mariyabasapur9811253@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhu M |
| Designation |
Associate Professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Hassan. |
| Address |
OPD-20, Department of Prasuti Tantra and Stri roga,Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Thanniruhalla, B.M. Road
Hassan
KARNATAKA
573201
India |
| Phone |
8970167939 |
| Fax |
|
| Email |
drmadhuayu@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mariyamma |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Thanniruhalla, B.M. Road, Hassan. |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Thanniruhalla, B.M. Road
Hassan
KARNATAKA
573201
India |
| Phone |
8073429292 |
| Fax |
|
| Email |
mariyabasapur9811253@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala College of Ayurveda and Hospital Thanniruhalla BMRoad HassanManjunatheshwara College of Ayurveda and Hospital Thanniruhalla BMRoad Hassan,Karnataka,India Phone No -08172256460, E- mail- sdmcah@gmail.com |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla BMRoad Hassan |
| Address |
Department of Prasuti Tantra and Stri Roga,Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla BMRoad Hassan |
| Type of Sponsor |
Private medical college |
|
|
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 Mariyamma |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospitallla,Hassan, |
OPD-20, Department of Prasuti Tantra and Stri Roga,Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,Thanniruhalla, B.M. Road, Phone No-08217239866, E-mail- sdmcah@gmail.com
Hassan
KARNATAKA |
8073429292
mariyabasapur9811253@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee. 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 | Procedure | - | yoni picu, योनि पिचॠ| (Procedure Reference: Charaka Samhita, Procedure details: A sterile pichu of 3*3 cm is soaked in 5 ml of Pancha kashaya taila is kept per vaginally.Retain pichu till Aamutrakala.)
(1) Medicine Name: Panchakashaya Taila, Reference: Bhavaprakasha, Route: Vaginal, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | yoni dhAvana, योनि धावन | (Procedure Reference: Charaka Samhita, Procedure details: Yoni Prakshalana is done with Sukoshana Raajavrukshadi kashaya-500 ml for 15 minutes. The cervix is mopped using a sterile gauze piece. )
(1) Medicine Name: Raajavrukshadi kashaya, Reference: Bhavaprakasha, Route: Vaginal, Dosage Form: Kwatha/Kashaya, Dose: 500(ml), Frequency: bd, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
• Presence of Yonisrava and Yoni Kandu with or without Yoni alpavedana.
• Married women of age between 20-50years.
• Willing to sign the informed written consent form. |
|
| ExclusionCriteria |
| Details |
• Pregnant women
• Lactating women.
• Cervical pathology like Carcinoma of cervix, polyps, etc
• Subjects positive for HIV, VDRL, HBsAg
• Known case of Diabetes mellitus, pelvic inflammatory disease
• Post menopausal women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Major Symptoms like White Discharge per vagina, Vulval and vaginal itching. |
7th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of Low backache and White discharge per vagina and Foul smell. |
14th Day |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
09/10/2023 |
| 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="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
|
Among twenty Yonivyapat, Kaphaja yonivyapat is caused by the intake of abhisyandi ingredients, the aggravated kapha reaches the reproductive organs of women results in kandu,picchila-Shwetha yoni srava, Alpavedana and Panduvarna. Approximately In all women of reproductive age complaints of abnormal vaginal discharge, overall prevalence rate is 55.6% .White discharge per vagina is found in 76.3% and White discharge with foul smell is found in 49.6 %. Here in Kaphaja yoni vyapat, Raajavrukshadi kashaya Yoni praskhalana and Pancha kashaya taila Yoni Pichu is taken for study. These drugs contains katu, tikta, kashaya rasa, laghu,ruksha, tikshna guna, ushna virya, katu vipaka and kaphahara, vrana shodhana, kandughna properties which tend to reduce the kandu, shwetha-picchila yoni srava, durgandhata of yoni. Therefore in this study an effort has been put forth to evaluate the Effictiveness of Raajavrukshadi kashaya yoniprakshalana and Panchakashaya taila yoni Pichu. |