| CTRI Number |
CTRI/2026/01/100870 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
12/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Panchakarma procedure and ayurvedic medicine in the management of Eka Kushtha w.s.r. to Psoriasis |
|
Scientific Title of Study
|
A comparative study to evaluate the efficacy of Neem Patra Lepa with and without Virechana in the management of Eka Kushtha w.s.r. to 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 |
Dr Simran |
| Designation |
PG Scholar |
| Affiliation |
Dayanand Ayurvedic College, Jalandhar |
| Address |
Department of Panchakarma Dayanand Ayurvedic College and Hospital, Mahatma Hans Raj Marg, Jalandhar, Punjab, India
Jalandhar PUNJAB 144008 India |
| Phone |
8264813419 |
| Fax |
|
| Email |
simran190499@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Parveen Kumar |
| Designation |
Professor and HOD of Panchakarma |
| Affiliation |
Dayanand Ayurvedic College, Jalandhar |
| Address |
Department of Panchakarma Dayanand Ayurvedic College and Hospital, Mahatma Hans Raj Marg, Jalandhar, Punjab, India
Jalandhar PUNJAB 144008 India |
| Phone |
7589303536 |
| Fax |
|
| Email |
drparv1@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Simran |
| Designation |
PG Scholar |
| Affiliation |
Dayanand Ayurvedic College, Jalandhar |
| Address |
Department of Panchakarma Dayanand Ayurvedic College and Hospital, Mahatma Hans Raj Marg, Jalandhar, Punjab, India
Jalandhar PUNJAB 144008 India |
| Phone |
8264813426 |
| Fax |
|
| Email |
simran190499@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Ayurvedic College and Hospital, Mahatma Hans Raj Marg, Jalandhar, Punjab, 144008, India |
|
|
Primary Sponsor
|
| Name |
Dayanand Ayurvedic College and Hospital, Jalandhar |
| Address |
Department of Panchakarma, Dayanand Ayurvedic College and Hospital, Mahatma Hans Raj Marg, opp Burlton Park, Jalandhar, Punjab, 144008, India |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Simran |
Dayanand Ayurvedic College and Hospital, Jalandhar |
Department of Panchakarma, Dayanand Ayurvedic College and Hospital, Mahatma Hans Raj Marg, Jalandhar, Punjab, 144008, India Jalandhar PUNJAB |
08264813426
simran190499@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DAC Institutinal Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:L400||Psoriasis vulgaris. Ayurveda Condition: EKAKUSHTHAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Neem Patra Lepa, Reference: Charak Sutra 3/3, Route: Topical, Dosage Form: Churna/ Powder, Dose: 50(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Dried Neem Patra is made into a fine powder. Before local application on the
body, it is mixed with Sarsharpa Tail (Mustard oil) and made into soft paste. | | 2 | Comparator Arm | Procedure | - | virecana-karma, विरेचन-कर्म | (Procedure Reference: Charak Chikitsa 7/41, Procedure details: Ama Pachana will be carried out by using Chitrakadi vati in a dose of 1 tablet 3 times a day before food with warm water until Nirama lakshanas appear.Subsequently, Abhayantara Snehana with Mahatikta ghrita will be administered as Snehapana early in the morning (between 6:30-7:30 am) on an empty stomach in Arohana karma, until the appearance of Samyaka Snigdha Lakshana. Here, Anupana of Snehapana will be lukewarm water. Dose will be decided as per status of Kostha and Agni of the patient. After the appearance of Samyaka Snigdha lakshana, Sarvanga Abhyanga with Murchita Tila Taila followed by Bashpasweda, will be done for 3 days. On the day of Shodhana, Virechana will be done with Triphala kwath along with Trivrut churna and Dantimool churna on an empty stomach, after Sarvanga Abhyanga and Sweda in the morning. Dose will be decided as per status of Koshtha and Agni of the patient. Peyadi Samsarjana karma will be advised for 3-7 days as per Shuddhi Prakara. Maximum Duration for procedure will be 23 days.)) (1) Medicine Name: Triphala kwath along with Trivrut churna and Dantimool churna, Reference: Bhaishajya Ratnavali, Kushtharogadhikar, 54/4, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 100(ml), Frequency: od, Duration: 1 Days |
|
|
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Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients fulfilling the diagnostic criteria of Eka Kushtha.
2. Patients of all varieties of Psoriasis will be selected.
3. Patient of either sex.
4.Patient between the age group of 16-60 years.
5.Both fresh and treated cases of Eka-Kushtha, which have already discontinued other treatments, will be selected.
6.Patients who are fit for Virechana Karma.
|
|
| ExclusionCriteria |
| Details |
1. Patient with other systemic disorders like uncontrolled Diabetes Mellitus type 2 and Hypertension, which interfere with the treatment.
2. Eka-Kushtha (Psoriasis) with extra cutaneous manifestations.
3. The patient has had chronicity for more than 15 years
|
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Aswedanam (anhidrosis/ lack of sweating).
2. Mahavastu (broad-based)
3. Matshyashakalopamam (looks like the scales of a fish).
4. Krishana-arun varna (blackish red discoloration). |
Assessment of the patient will be done on day 1st, 16th, 30th and 45th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Auspitz Sign
2. Candle grease sign
3. PASI Score |
Assessment of the patient will be done on day 1st, 16th, 30th and 45th |
|
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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 |
|
Date of First Enrollment (India)
|
23/01/2026 |
| 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
|
Psoriasis is a chronic inflammatory skin disorder with increasing prevalence. Modern treatments such as corticosteroids, methotrexate, cyclosporine, and biologics are effective, but their long-term use is associated with adverse effects, including hepatotoxicity, nephrotoxicity, immunosuppression, and increased economic burden, limiting their sustained use. Whereas, Ayurveda Panchakarma therapies have a bright scope in managing psoriasis. Psoriasis is correlated with Kushtha, involving predominant Vata and Kapha dosha vitiation. This study will be undertaken to evaluate an alternative Ayurvedic approach. In this trial, we are evaluating the effect of Neem patra lepa with and without Virechana in the management of Eka Kushtha w.s.r. Psoriasis with the aim to develop and evaluate a new treatment modality for this disease. |