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CTRI Number  CTRI/2025/04/085437 [Registered on: 23/04/2025] Trial Registered Prospectively
Last Modified On: 09/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Use of Somarajyadi lepa and its ointment in psoriasis  
Scientific Title of Study   Randomized controlled clinical trials to evaluate the efficacy of Somarajyadi lepa and its ointment in case of Dushivishjanya Ekakustha 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 Mandakini Eknath Thokal  
Designation  PG Scholar  
Affiliation  GAC Dharashiv 
Address  Agadtantra Department opd no 12 Ground Floor Government Ayurvedic college and Hospital Tuljapur Road Dharashiv

Osmanabad
MAHARASHTRA
413501
India 
Phone  7040474890  
Fax    
Email  mandakinithokal22@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr S P Mirajkar Koparde 
Designation  Associate Professor of Agadtantra Department  
Affiliation  GAC Dharashiv 
Address  Agadtantra Department opd no 12 Ground Floor Government Ayurvedic college and Hospital Tuljapur Road Dharashiv
Government Ayurvedic college Dharashiv
Osmanabad
MAHARASHTRA
413501
India 
Phone  9326141020  
Fax    
Email  drkopardesheetal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr S P Mirajkar Koparde 
Designation  Associate Professor of Agadtantra Department  
Affiliation  GAC Dharashiv 
Address  Agadtantra Department opd no 12 Ground Floor Government Ayurvedic college and Hospital Tuljapur Road Dharashiv
Government Ayurvedic college Dharashiv
Osmanabad
MAHARASHTRA
413501
India 
Phone  9326141020  
Fax    
Email  drkopardesheetal@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurvedic college and Hospital Tuljapur Road Dharashiv 413501 
 
Primary Sponsor  
Name  Government Ayurvedic college and Hospital Dharashiv  
Address  Government Ayurvedic college and Hospital Tuljapur Road Dharashiv Maharashtra India 413501 
Type of Sponsor  Other [Government Ayurvedic college and Hospital Dharashiv ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Mandakini Eknath Thokal   Government Ayurvedic college and Hospital Dharashiv   Agadtantra Department opd no 12 Ground Floor Government Ayurvedic college and Hospital Tuljapur Road Dharashiv
Osmanabad
MAHARASHTRA 		 7040474890

mandakinithokal22@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Government Ayurvedic college Dharashiv Maharashtra India 413501  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L400||Psoriasis vulgaris. Ayurveda Condition: EKAKUSHTHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Clobetasol ointment Local application before night as per requirement for 30 days.
2Intervention ArmDrugClassical(1) Medicine Name: Somarajyadi lepa , Reference: Sushrut samhita kalpa sthan, Route: Topical, Dosage Form: Lepa Churna, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Application with jala.
3Intervention ArmDrugClassical(1) Medicine Name: Somarajyadi ointment , Reference: Rasatarangini Malhara kalpana , Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 5(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.patients diagnosed with Dushivishjanya Ekakushta.
2.Age Group above 5 years.
3.Patient of either sex.
 
 
ExclusionCriteria 
Details  1.Patients of osteoarthritis, Rheumatoid arthritis,SLE,psoratic arthritis,postular valgarius.
2.Psoriasis vulgarius associated with other complicate disease.
3.Patients having Diabetes mellitus,koche.
4.Patients with HIV,VDRL,HBsAg positive.
5. Non willing patients. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study the efficacy of Somarajyadi lepa in its onintment in Ekakushta  On 7th,14th,21st,28th day of trial. 
 
Secondary Outcome  
Outcome  TimePoints 
1.To study the Somarajyadi lepa in detail.
2.To study Ekakushta in detail as per ayurveda and modern text.
3.Authentification and standardization of raw ingredients of Somarajyadi lepa.
4.Pharmacetical and analytical study of Somarajyadi ointment.
5.Safty study in vivo authorised animals testing lab  		 On 7th,14th,21th,28th day of trial. 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   03/05/2025 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mandakinithokal22@gmail.com].

  6. For how long will this data be available start date provided 31-10-2025 and end date provided 15-03-2030?
    Response (Others) -  Date mention

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Thank you
Brief Summary   After clearance of institutional ethics committee of Government Ayurvedic college Dharashiv screening of population will be done from patient in OPD, IPD of our institute, Civil Hospital and periphery. In clinical study of 90 patients of Psoriasis(Ekakushta) will include. If patients fulfill the criteria of inclusion, subject would also given freedom to ask their questions all questions would answer. If he/she agrees for participation in study and found fit to include the patient will include in the study.
The treatment will be given to patient as follows:

Group A (Trial Group) : Somarajyadi lepa- 5 gm BD (30 Days) Local Application with jala.

Group B (Trial Group) : Somarajyadi ointment - 5 gm HS (30 days) Local Application.

Group C ( control Group):
Clobetasol ointment -5 gm HS (30 days) Local Application.

In study Assessment of Grading scale of symptoms and PASI Score will be assessed as per need on 7th , 14th , 21th Day and final assessment of patient will be done on 28th day.

Medium of Dissertation: The study will be written in English and Sanskrit words will be used wherever necessary.

Study Design: Open Randomized Controlled Clinical Trial.

Duration of Treatment: 30 days

Ethical Clearance: Clearance from Institutional Ethics Committee will be taken.

Study Centre: OPD, IPD of Mother institute, Civil Hospital and periphery.

Duration of study: Study will be carried out for 18 months.

Study Population:

1. All the patients of Ekakushta (Psoriasis) attending OPD, IPD of our institute , civil Hospital and periphery of our institute will be considered in this study.

2. Patients in between 5 to 60 years of age.

3. Patients will be diagnosed on the basis of symptoms and PASI Score.

Sample Size: Sample size calculated by Daniel’s formula.


Daniel’s formula-

Sample size (n)= Z2 p(1-p)/e2

Where n = Sample Size

z= Level of Signification (1.96)

p =2% Highest Prevalence Rate (0.02)

e = Standard Error (5%)

n = (1.96)2 x 0.98÷ (0.05) 2 
 n=30.12 ~ 30.
For Statistical point of view total 30 patients will taken in each group.

Assessment will be done on the basis of following criteria’s:

A) Subjective Criteria:
  1.Gradation of Erythema (Aruna Varna).
  2.Gradation of Induration( Mandala).
  3.Gradation of Desquamation (Matsyashakalopama).
 4. PASI Score.


B) Objective Criteria:
  1. Photographic evidence before and after treatment.
2. Auspitz Sign.
3. Routine Hemogram.
4. Random Blood Sugar.

C) Overall Assessment Criteria - Overall assessment will be done on the basis of Marked Improvement, Moderate Improvement, Mild Improvement, No Improvement.

Finally, Observation, Discussion, Conclusion will be done.
 
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