| CTRI Number |
CTRI/2025/06/089524 [Registered on: 25/06/2025] Trial Registered Prospectively |
| Last Modified On: |
21/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
efficacy of virechana karma with trivrat churna and kusthadi churna lepa in vicharchika w.s.r. to wet
eczema comparative trial |
|
Scientific Title of Study
|
efficacy of virechana karma with trivrat churna and kusthadi churna lepa in vicharchika w.s.r. to wet
eczema comparative trial |
| 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 Uma Kushwah |
| Designation |
Pg Schlor Department of Panchakarma |
| Affiliation |
Govt. Auto Dhanwantari Ayurveda Medical College Mangalnath Marg Ujjain M.P. |
| Address |
Room No.22, Panchakarma Department
Nill
Ujjain
MADHYA PRADESH
456010
India |
| Phone |
8982860470 |
| Fax |
|
| Email |
drumakushwah86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nripendra Mishra |
| Designation |
Associate Professor |
| Affiliation |
Govt. Auto Dhanwantari Ayurveda Medical College Mangalnath Marg Ujjain M.P. |
| Address |
Room no. 22, Panchakarma Department
Ujjain
MADHYA PRADESH
456010
India |
| Phone |
9406660734 |
| Fax |
|
| Email |
mishranripendra.v@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Uma Kushwah |
| Designation |
Pg Schlor Department of Panchakarma |
| Affiliation |
Govt. Auto Dhanwantari Ayurveda Medical College Mangalnath Marg Ujjain M.P. |
| Address |
Room No.22, Panchakarma Department
Nill
Ujjain
MADHYA PRADESH
456010
India |
| Phone |
8982860470 |
| Fax |
|
| Email |
drumakushwah86@gmail.com |
|
|
Source of Monetary or Material Support
|
| govt. autonomus dhanwantari ayurveda college and hospital ujjain m.p. |
|
|
Primary Sponsor
|
| Name |
Govt.(Autonomus) Dhanwantari Ayurveda College And Hospital, Ujjain M.P. |
| Address |
Mangalnath marg Ujjain M.P.India Pin- 456006 |
| Type of Sponsor |
Government 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 Uma Kushwah |
Govt auto Dhanwantari Ayurveda medical college |
Room No.22, Panchakarma Department
Ujjain
MADHYA PRADESH |
08982860470
drumakushwah86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee govt. dhanwantri ayurvedic college and hospital ujjain mp. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L989||Disorder of the skin and subcutaneous tissue, unspecified. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kushthadi churna lepa, Reference: Charak Sutra Sthana 3/11, Route: Topical, Dosage Form: Churna/ Powder, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: Local application of Kushthadi churna lepa | | 2 | Comparator Arm | Procedure | - | Virechnakarma and Kushthadi Churna Lepa | (Procedure Reference: Charak Chikitsa Sthana 7/39 and 7/44, Procedure details: Deepana-Pachana with Panchkola-phant till niram awatha
Snehana-1. Abhyantar Snehapana Go-grita with lukewarm water till samayaka snigdht lakshana appear
2.Bahaya Abhayanga with til tail
Swedana Vaspa sweda till samayaka swedana lakshana appear
Pradhana Karma-Trivratchurna 30g with madhu as per requirement samayaka Virechana lakshana appear
Paschat karma sansarjana karma accounding to suddhi of virechana karma)
(1) Medicine Name: Trivrat churna , Reference: Charak Chikitsa Sthana 7/44, Route: Oral, Dosage Form: Churna/ Powder, Dose: 30(g), Frequency: od, Duration: 1 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients fullfilling the signs and symptoms of Vicharchika Wet Eczema according to Ayurvedic and modern Literatures.
2 Patients of age group between 18 to 60 years irrespective of sex religion socioeconomic status and occupation.
|
|
| ExclusionCriteria |
| Details |
1] Patients below the age of 18 year and above the age of 60 years.
• 2] Patient with other Systemic Disease like Diabetes mellitus, Ischeamic heart disease, Tuberculosis , etc.
• 3] Pregnant and Lactating Women.
• 4] Patient not ready to Sign the consent and unable to comply with the protocol.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to reduce the intensity of classical signs and symptoms of Vicharchika wet Eczema like Kandu Daha Ruja Pidika Shyavata Srava 4 wks |
to reduce the intensity of classical signs and symptoms of Vicharchika wet Eczema like Kandu Daha Ruja Pidika Shyavata Srava 8wks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effective managment of classical signs and symptoms of Vicharchika (wet Eczema) by relieving the symptomps like Kandu, Daha, Ruja, Pidika, Shyavata, Srava, |
60 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)
|
27/07/2025 |
| 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="2"
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 will be designed as a Randomized Controlled clinical study and the participants will be selected from simple purposive sample technique. All the 60 patients randomly selected will be divided into 2 groups having 30 patients in each group. Group A of 30 patients will be administered Virechana karma with trivrat churna and kusthadi churna lepa in the management of Vicharchika (Weeping Eczema). Group B 30 patients of this group will be applied kusthadi churna lepa. Study duration is 2 months and follow up period on every 15th days. Both groups patients will be further followed up for 30th day to observe the clinical outcome. |