| CTRI Number |
CTRI/2025/09/095360 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
24/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of Vamana Karma with Madanphala Kalpa and Jeemutaka Kalpa in Ek Kushtha with respect to Psoriasis |
|
Scientific Title of Study
|
Comparative Clinical Evaluation Of Vamana Karma With Madanphal Kalpa And Jeemutak Kalpa In Ek Kushtha(Psoriasis) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajat Ramola |
| 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 Uttrakhand
Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9997224498 |
| Fax |
|
| Email |
rajat.ramola1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Piyush 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 Uttrakhand
Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8954890277 |
| Fax |
|
| Email |
drpiyushgupta3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajat Ramola |
| 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 Uttrakhand
Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9997224498 |
| Fax |
|
| Email |
rajat.ramola1993@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthsan, Haridwar |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthsan, Haridwar |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthsan, Patanjali Yogpeeth Phase 1,Roorkee Road Haridwar Uttarakhand |
| 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 |
| Rajat Ramola |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthsan, Haridwar |
Panchakarma Department Opd no.4 Patanjali Ayurveda Hospital Patanjali Yogpeeth Phase 1 Roorkee Road Haridwar Uttrakhand
Haridwar
Hardwar
UTTARANCHAL |
09997224498
rajat.ramola1993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee ,Patanjali Ayurved College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L409||Psoriasis, unspecified. Ayurveda Condition: EKAKUSHTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | vamana-karma/ pracCardanam, वमन-कर्म/ प्रच्छर्दनम् | (Procedure Reference: Charak Samhita Kalpa Sthan 2/6, Procedure details: POORVA KARMA: Langhana -Deepana – Pachana with Panchkol Churna is given till the Niram Lakshna. Abhyantara Snehapana will be carried out by Panchatikta Ghrita in increasing dose Starting from 30 ml till Samyak snigdh lakshana.
PRADHANA KARMA: After proper Snehana–Swedana, patients will be given Vaman Yoga. Jeemutaka Kalpa will be given according to the kostha of the patient.
Vamana yoga with a sufficient quantity of Yashtimadhu Phanta followed by lavanodak Anupana will be administered to patients in the morning. Then Shuddhi Lakshana in terms of Laingiki,
Vaigiki, Antiki, and Manki will be assessed.
PASCHAT KARMA: After the successful completion of Vamana, the patients will be asked to follow all the precautions related to Vamana. Samsarjana Krama will be given as per the type of
Shuddhi Lakshana and in the sequence mentioned by the classics. )
(1) Medicine Name: Jeemutak Peya, Reference: Charak Samhita Kalpa Sthan 2/6, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 6(g), Frequency: od, Duration: 10 Days | | 2 | Comparator Arm | Procedure | - | vamana-karma/ pracCardanam, वमन-कर्म/ प्रच्छर्दनम् | (Procedure Reference: Charak Samhita Kalpa Sthan 1/14, Procedure details: POORVA KARMA: Langhana -Deepana – Pachana with Panchkol Churna is given till the Niram Lakshna. Abhyantara Snehapana will be carried out by Panchatikta Ghrita in increasing dose Starting from 30 ml till Samyak snigdh lakshana.
PRADHANA KARMA: After proper Snehana–Swedana, patients will be given Vaman Yoga. Madanphal Kalpa will be given according to the kostha of the patient.
Vamana yoga with a sufficient quantity of Yashtimadhu Phanta followed by lavanodak Anupana will be administered to patients in the morning. Then Shuddhi Lakshana in terms of Laingiki,
Vaigiki, Antiki, and Manki will be assessed.
PASCHAT KARMA: After the successful completion of Vamana, the patients will be asked to follow all the precautions related to Vamana. Samsarjana Krama will be given as per the type of
Shuddhi Lakshana and in the sequence mentioned by the classics. )
(1) Medicine Name: Madanphal Yog , Reference: Charak Samhita Kalpa Sthan 1/14, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(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 between the age group 18-60 years of either sex.
2.Patients with classical features of Ek Kushtha explained in classical text.
3.Patients will be selected irrespective of sex,occupation,Socio economic status,religion etc
4.Both fresh and treated cases will be selected.
5.Patients fit for Vamana Karma will be taken for study. |
|
| ExclusionCriteria |
| Details |
1.Patients below the age of 18 years and above 60 years were excluded.
2.Patients with Hypertension,Cardiac Disorder, Diabetes Mellitus and Major systemic disease.
3.Patients having other Skin Disorders like Chornic Fungal Infection,Tuberculosis,SLE.
4.Psychiatric illnesss and pregnant women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Matsyashaklapaman
Aswedanam
Mahavastum
Arun Varna
Kandu
Rukshta
Daha
Srava |
10,60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Candle Grease Sign
Auspitz Sign
Koebner Phenomenon
Assesssment Of Deha Prakriti Of Patient - Deha prakriti of patient will be assessed on the proforma prepared on the Ayurvedic concept according to Doshik features. Analysis will be made for the evaluation of incidence or association of the disease with the type of Deha Prakriti. |
10,60 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)
|
05/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/10/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 Vamana Karma With Madanphal Kalpa and Jeemutak Kalpa in Ek Kushtha (PSORIASIS). This will be conducted on 50 randomly selected patients from the OPD/ IPD of the Panchakarma Department of Patanjali Bhartiya Ayurvigyan Evum Anusandhan Sansthan Haridwar. Patients will be divided into two groups: 25 patients will be administered Vamana Karma with Madanphal Kalpa, and 25 patients will be administered Vamana Karma with Jeemutak Kalpa. Follow up will be taken after 2 months of assessment to be done on the basis of subjective and objective parameters as discussed earlier. |