| CTRI Number |
CTRI/2025/01/079352 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of Virechana Karma with Abhayadi Modak and Trivrit Churna in Vicharchika (Eczema) |
|
Scientific Title of Study
|
A Comparative Clinical Evaluation Of Virechana Karma With Abhayadi Modak And Trivrit Churna In Vicharchika (Eczema) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Joshi |
| Designation |
PG Scholar Panchakarma |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar |
| Address |
Panchakarma Department Opd no 4 Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1 Roorkee Road Haridwar Uttarakhand
Haridwar
UTTARANCHAL
249405
India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9634705199 |
| Fax |
|
| Email |
priyankaayurveda01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchi Gupta |
| Designation |
Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar |
| Address |
Panchakarma Department Opd no 4 Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1 Roorkee Road Haridwar Uttarakhand
Haridwar
India
UTTARANCHAL
249405
India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9469063888 |
| Fax |
|
| Email |
ruchigupta1610@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Joshi |
| Designation |
PG Scholar Panchakarma |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar |
| Address |
Panchakarma Department OPD no 4 Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1 Roorkee Road Haridwar Uttarakhand
Haridwar
UTTARANCHAL
249405
India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9634705199 |
| Fax |
|
| Email |
priyankaayurveda01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan,Patanjali Yogpeeth Haridwar,India
pincode-249405 |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Patanjali Yogpeeth Phase 1 Roorkee Road Haridwar Uttarakhand pincode 249405
India
|
| 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 Priyanka Joshi |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar |
Department of Panchakarma, OPD no 4,Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Patanjali Yogpeeth Phase 1 Roorkee road Haridwar India pincode 249405
Hardwar
UTTARANCHAL |
9634705199
priyankaayurveda01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Patanjali Ayurveda College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L209||Atopic dermatitis, unspecified. Ayurveda Condition: VICARCIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-कर्म | (Procedure Reference: Sharangdhar Samhita Uttarakhand 4/26-33, Procedure details: Procedure Reference: Charak Chikitsha 7/39, Procedure details: POORVA KARMA: Langhana & Deepana-Pachana with Chitrakadi Vati will bebgiven till the Niram Lakshna. Abhyantara Snehapana will be carried out by Panchatikta Ghrita in increasing dose starting from 30 ml till Samyak Snigdha Lakshanas. PRADHANA KARMA: After proper Snehan-Swedan, patients will be given Virechana Yoga on empty stomach. Abhayadi Modak with a minimum dose of 1-3 will be given to the patient. According to Koshtha, age and sex of patient dose may be increased or decreased. Virechana Yoga Abhayadi Modak with sufficient quantity of Sheeta jala as Anupana will be administered to patients in the morning hours in between 9:30-10:00 AM. Then Shuddhi Lakshana in terms of Laingiki, Vaigiki, Antiki, and Maniki will be assessed. PASCHAT KARMA: After the successful completion of Virechana Karma, the patients will be asked to follow all the precautions related to Virechana. Samsarjana Krama will be given as per type of Shuddhi Lakshana and in sequence mentioned by classics.
(1) Medicine Name: Abhayadi Modak, Reference: Sharangdhar Samhita Uttarakhand 4/26-33, Route: Oral, Dosage Form: Modaka, Dose: 2(NA), Frequency: od, Duration: 10 Days
)
(1) Medicine Name: Abhayadi Modak , Reference: Sharangdhar Samhita Uttarakhand 4/26-33, Route: Oral, Dosage Form: Modaka, Dose: 2(NA), Frequency: od, Duration: 10 Days | | 2 | Comparator Arm | Procedure | - | virecana-karma, विरेचन-कर्म | (Procedure Reference: A Textbook of Panchkarma by Dr B. A Lohith, Chaukhambha Orientalia, Varanasi, chapter - 5, page no 252, Procedure details: Procedure Reference: Charak Chikitsha 7/39, Procedure details: POORVA KARMA: Langhana & Deepana-Pachana with Chitrakadi Vati will be given till the Niram Lakshna. Abhyantara Snehapana will be carried out by Panchatikta Ghrita in increasing dose starting from 30 ml till Samyak Snigdha Lakshanas. PRADHANA KARMA: After proper Snehan-Swedan, patients will be given Virechana Yoga on empty stomach. Trivrit Churna with a minimum dose 30- 50 gms will be given to the patient. According to Koshtha, age and sex of patient dose may be increased or decreased. Virechana Yoga Trivrit Churna with sufficient quantity of Ushna Jala as Anupana will be administered to patients in the morning hours in between 9:30-10:00 AM. Then Shuddhi Lakshana in terms of Laingiki, Vaigiki, Antiki, and Maniki will be assessed. PASCHAT KARMA: After the successful completion of Virechana Karma, the patients will be asked to follow all the precautions related to Virechana. Samsarjana Krama will be given as per type of Shuddhi Lakshana and in sequence mentioned by classics.
(2) Medicine Name: Trivrit Churna, Reference: A Textbook of Panchkarma by Dr. B. A. Lohith, Chaukhambha Orientalia, Varanasi, chapter- 5, page no 252, Route: Oral, Dosage Form: Churna/ Powder, Dose: 30(g), Frequency: od, Duration: 10 Days)
(1) Medicine Name: Trivrit Churna, Reference: A Textbook of Panchkarma by Dr B. A Lohith, Chaukhambha Orientalia, Varanasi, chapter - 5, page no 252, Route: Oral, Dosage Form: Churna/ Powder, Dose: 30(g), Frequency: od, Duration: 10 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients will be diagnosed on the basis of classical symptoms of Vicharchika (Eczema).
2.Patients of age between 18 years-60 years.
3.Patients willing to participate in this trial.
4.Patients fit for Virechana Karma procedure with diagnosis of Vicharchika. |
|
| ExclusionCriteria |
| Details |
1.Uncontrolled diabetes mellitus, hypertension and other previously diagnosed life threatening and complicated diseases.
2.Patients of age below 18 years and above the age of 60 years.
3.Any other clinically diagnosed skin diseases.
4.Pregnant and lactating women.
5.Patients not fit for Virechana Karma. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Parameters that will be assessed:-
1.Kandu(Itching)
2.Pidika(Eruption)
3.Srava(Discharge)
4.Shyavata(Discolouration)
5.Rukshata(Dryness) |
10,30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Redness
2.Thickness
3.Lichenification |
10,30 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
03/02/2025 |
| 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="1"
Months="6"
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 a Comparative Clinical Evaluation of Virechana Karma with Abhayadi Modak and Trivrit Churna in Vicharchika (Eczema)
This will be conducted on 50 randomly selected patients from Opd/Ipd of Panchakarma department of Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan Haridwar. Patient will be divided into 2 groups- 25 patients will be administered Virechana Karma with Abhayadi Modak and 25 patients will be administered Virechana Karma with Trivrit Churna. Follow up will be taken after 1 month assessment to be done on the basis of subjective and objective parameters as discussed earlier. |