Use of Somarajyadi lepa and its ointment in psoriasis

Phase 2/3

Not yet recruiting

• Conditions: Psoriasis vulgaris. Ayurveda Condition: EKAKUSHTHAH,

• Registration Number: CTRI/2025/04/085437
• Lead Sponsor: Government Ayurvedic college and Hospital Dharashiv

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-03-05
• Last Update Posted: 2025-09-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 1.patients diagnosed with Dushivishjanya Ekakushta.
• 2.Age Group above 5 years.
• 3.Patient of either sex.

Exclusion Criteria

• 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.
• Non willing patients.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study the efficacy of Somarajyadi lepa in its onintment in Ekakushta	On 7th,14th,21st,28th day of trial.

Secondary Outcome Measures

Name	Time	Method
1.To study the Somarajyadi lepa in detail.	2.To study Ekakushta in detail as per ayurveda and modern text.

Trial Locations

Locations (1)

Government Ayurvedic college and Hospital Dharashiv; 🇮🇳 Osmanabad, MAHARASHTRA, India

Government Ayurvedic college and Hospital Dharashiv

🇮🇳Osmanabad, MAHARASHTRA, India

Dr Mandakini Eknath Thokal

Principal investigator

7040474890

mandakinithokal22@gmail.com