Comparative clinical study to evaluate efficacy of khadiradi kashay with dadrudavanal lepa in the management of dadru with special reference to Tinea corporis
Trial Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- To reduce signs and symptoms of dadru (Tinea corporis)
Study Overview
Brief Summary
Primary Objectives-1.To evaluate & compare the efficacy of khadiradi kashay & dadrudavanadi lepa in the management of Dadru based on clinical improvement in signs & symptoms including kandu (itching),Raga(Erythema or Redness),Pidika (Eruption),Utsanna mandala (Elevated circular skin Lesion),No of Pidika & size of lesion.
Secondary Objectives-1.To compare the duration required for significant symptomatic relief & lesion clearance in treatment groups.
2)To study the recurrence of infection within a specific follow up period after completion of therapy
3)To determine whether a combination therapy (oral +topical)provides superior results compared to either alone drug.
Participants - 90 adults diagnosed with dadru meeting inclusion & exclusion criteria from shree Saptshrungi Ayurved Mahavidyalay And Hospital Nashik.
Interventions -
Group A-Khadiradi kashay internally for 15 days
Group B-Dadrudavanadi lepa externally (LA) 15 days
Group C-Khadiradi kashay internally and Dadrudavanadi lepa externally (LA)
Treatment duration-15 days
Follow up - 0 ,7 th & 15 th day
Data Analysis- Data will be analysed using appropriate statistical Methods to compare the effectiveness of the intervention on the primary and secondary outcomes.
Ethical Consideration-The study will be conducted in accordance with Ethical Guidelines & with informed consent from participants.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with classical sign &symptoms of Dadru I.e.kandu,Pidikotpatti, Raga,Utsanna mandala.
- •Patients of either gender and age group between 18-60 years irrespective of religion, occupation and socio-economic status will be selected.
- •Patients having symptoms of dadru kushta within the time period of 6 months.
Exclusion Criteria
- •Patients of Dadru with any secondary complication.
- •Patients who are suffering from any other type of skin disease like Herpes zoster, eczema.
- •Patients who are suffering from any other known case of systemic Diseases I.e.uncontrolled DM etc.
- •Pregnant and lactating women 5)Patients taking immunosuppressive medications.
Outcomes
Primary Outcomes
To reduce signs and symptoms of dadru (Tinea corporis)
Time Frame: 7th day
Secondary Outcomes
- To reduce signs and symptoms of dadru (Tinea Corporis)(To reduce recurrence rate of Dadru (Tinea corporis))