Randomized Controlled Clinical Trial to evaluate the efficacy of Siddharthak Gel over Siddharthak Lepa in the management of Dadrukushtha (Tinea Corporis)
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Dr Ajit Vijaykumar Patil
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Global Assessment Score (GAS) based on the evaluation of six signs and symptoms of Dadrukushtha (Tinea Corporis):
Overview
Brief Summary
The present study is a randomized, controlled, open label clinical trial designed to evaluate and compare the efficacy of Siddharthak Gel and Siddharthak Lepa in the management of Dadrukushtha Tinea Corporis. Eighty patients diagnosed with Dadrukushtha aged between 20 and 50 years will be randomly allocated into two groups. The Siddharthak Gel group will receive topical application of a gel based Siddharthak formulation while the Siddharthak Lepa group will receive a traditional Lepa application. Primary outcome measures include the assessment of Kandu itching, Raga redness, Visarpana spreading, Tamra varna coppery discoloration, Pidaka papules, and Mandala lesion characteristics using Global Assessment Scoring GAS. Secondary outcomes include changes in the Dermatology Life Quality Index DLQI and monitoring of adverse events. The study hypothesis is that Siddharthak Gel offers superior or equivalent clinical outcomes with better patient compliance compared to traditional Siddharthak Lepa.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 20.00 Year(s) to 50.00 Year(s) (—)
Inclusion Criteria
- •20 to 50 years age of group participants irrespective of Gender Religion Socio-economic and Marital Status suffering from dadrukushtha (Tinea corporis) 2) Participant assessed and diagnosed thoroughly based on Ayurvedic classical signs & symptoms of dadrukushtha 3) Participant having multiple lesions of dadrukushtha on body.
Exclusion Criteria
- •Known participant with history of other systemic disorders like diabetes mellitus HIV Tuberculosis etc 2) Participant’s receiving prolonged immunosuppressant and antibiotic therapy 3) Known participant having history of Chronic and severe cases associated with complications or secondary infection 4) Treated case & those who were received topical antifungal treatment within 1 week before baseline visit 5) Participant Currently receiving anti-fungal treatments like systemic or local 6) Participant suffering from other skin diseases than dadru like psoriasis, herpes etc.
Outcomes
Primary Outcomes
Global Assessment Score (GAS) based on the evaluation of six signs and symptoms of Dadrukushtha (Tinea Corporis):
Time Frame: • Day 0 (Baseline) | • Day 7 (First Follow-up) | • Day 15 (End of Treatment)
• Kandu (itching)
Time Frame: • Day 0 (Baseline) | • Day 7 (First Follow-up) | • Day 15 (End of Treatment)
• Raga (redness)
Time Frame: • Day 0 (Baseline) | • Day 7 (First Follow-up) | • Day 15 (End of Treatment)
• Visarpana (spreading of lesion)
Time Frame: • Day 0 (Baseline) | • Day 7 (First Follow-up) | • Day 15 (End of Treatment)
• Tamra Varna (coppery discoloration)
Time Frame: • Day 0 (Baseline) | • Day 7 (First Follow-up) | • Day 15 (End of Treatment)
• Pidaka (papular eruptions)
Time Frame: • Day 0 (Baseline) | • Day 7 (First Follow-up) | • Day 15 (End of Treatment)
• Mandala (number and size of circular lesions)
Time Frame: • Day 0 (Baseline) | • Day 7 (First Follow-up) | • Day 15 (End of Treatment)
Each parameter will be assessed using a 0–3 severity scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe).
Time Frame: • Day 0 (Baseline) | • Day 7 (First Follow-up) | • Day 15 (End of Treatment)
The total GAS will be calculated by summing the scores of all parameters (Range: 0–18).
Time Frame: • Day 0 (Baseline) | • Day 7 (First Follow-up) | • Day 15 (End of Treatment)
Secondary Outcomes
- DLQI (Dermatology Life Quality Index) Score(Day 0, Day 15)
Investigators
Dr Ajit Vijaykumar Patil
Tilak Ayurved Mahavidyalaya Pune