| CTRI Number |
CTRI/2025/02/079875 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
01/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of eczema with panchakarama purgation therapy by using intervention of Manibhadra avaleha |
|
Scientific Title of Study
|
Clinical evaluation of Virechan karma with Manibhadra Leham in the management of Vicharchika |
| 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. Riya Patil |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital, Pune |
| Address |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved Department of Panchakarma OPD No. 21 Dhankawadi Katraj Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9623214360 |
| Fax |
|
| Email |
riya.patil-ayurved@bvp.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Manjula Matekar |
| Designation |
Associate Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital, Pune |
| Address |
Department of Panchakarma OPD No. 21 Bharati Vidyapeeth (Deemed to be University) College of Ayurved Dhankawadi Katraj
Pune
MAHARASHTRA
411043
India |
| Phone |
9890254424 |
| Fax |
|
| Email |
manju.matekar@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Manjula Matekar |
| Designation |
Associate Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital, Pune |
| Address |
Department of Panchakarma OPD No. 21 Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital Dhankawadi Katraj
Pune
MAHARASHTRA
411043
India |
| Phone |
9890254424 |
| Fax |
|
| Email |
manju.matekar@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital Department Of Panchakarma Room No21 Dhankawadi Katraj Pune 411043 |
|
|
Primary Sponsor
|
| Name |
Dr Riya Patil |
| Address |
Bharati Vidyapeeth (Deemed to be University) College of Ayuved and Hospital Department of Panchkarma OPD No 21 Dhankawadi Katraj Pune 411043 |
| 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 |
| Riya Patil |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital Pune |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital Department of Panchakarma OPD No. 21 Dhankawadi Katraj Pune 411043
Pune
MAHARASHTRA |
919623214360
riya.patil-ayurved@bvp.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L309||Dermatitis, unspecified. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: manibhadra leham, Reference: Ashtang Hrudaya Chikitsasthan 19/31-32, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 80(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Days, anupAna/sahapAna: Yes(details: Koshna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having sign and symptoms of vicharchika diagnosed with the help of respective ayurvedic parameters
2. Virechan indicated patients |
|
| ExclusionCriteria |
| Details |
1. patients contraindicated for virechan karma
2. patients with complications like cardiac problems, emphysema, carcinoma and any anorectal disorder, etc.
3. pregnant woman and lactating mothers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in signs and symptoms like kandu(itching),pidaka(postule),shyava varna(discoloration),Daha(burning sensation), ruja(pain )
|
Improvement in signs and symptoms on 15th day and 30th day of snehapan |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in signs & symptoms in eczema like kandu itching pidaka pustule shyava varna discoloration Daha burning sensation ruja pain
|
Baseline 2 weeks & 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
16/02/2025 |
| Date of Study Completion (India) |
18/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
In particular, having good skin is a pre-requisite for both physical attractiveness and a desirable disposition. Because of its obvious disease, any skin deficiency makes a person severely disabled in today’s society. All skin conditions are covered by Ayurveda under the types of Kushtha; thus, it can be categorized as "Ayurvedic dermatology." One of the Kshudra Kushthas (Chronic skin disorders) is Vicharchika (NAMC ICD ED-4.3.10) falls under the category of Rakta Pradoshaja Vikaras. Since this illness is a kind of Kushtha, instances of recur and an extended duration are typical. Eighteen different forms of kushtha is formed as a result of sapta dravyas sangraha (vata, pitta, kapha and twak, rakta, mamsa, and ambu). Eczema, which is represented by recurrent or persistent skin rashes that have a chronic course and have a tendency to worsen, is comparable to vicharchika. Eczema is a non-communicable skin inflammation that presents with erythema, scaling, oedema, vesiculation, and oozing. Thus, in addition to treating it directly, it is crucial to address its recurrences when choosing a regimen for its complete eradication. Shodhana, or bio-purification, is necessary to eliminate the illness at its place of origin. When it comes to Panchakarma, Virechana (systemic purification via the use of purgative drugs) works better for skin conditions mostly caused by Pitta and Rakta. |