CTRI/2022/02/040587Not yet recruitingPhase 3
RANDOMISED CONTROLLED CLINICAL STUDY OF AROGYAMISHRAN ANDTANKANAMISHRAN IN DADRU W.S.R. TO TINEA
Dr Suryakiran Parashuram Wagh2 sites in 1 country120 target enrollmentStarted: January 3, 2022Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Cure of Dadru kushta signs and symptoms Kandu (Pruritus)
Study Overview
Brief Summary
Background of study is that Dadru wsr Tinea infections recurrence is high, there is need of long standing solution to avoid the recurrence of the disease. This is randomised controlled open clinical trial. both arms with 60 patients intervention for 15 days. Expected primary outcome is patients will became sign and symptom free and secondary outcome will that there should not be recurrence for 6 months.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Open Label
Eligibility Criteria
- Ages
- 14.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients having the clinical features of dadru.
- •Patients ready to abide trial procedure to give informed consent.
Exclusion Criteria
- •Patients aged below 14 & above 60 years.
- •Pregnant women & lactating mothers.
- •Patient of other skin disease like psoriasis, seborrhic dermatitis, lichen simplex, chronicus, pityriasis versicolor, eczema, candidiasis.
- •Patients having any known severe systemic diseases of renal, hepatic cardiac disorders, diabeties mellitus, tuberculosis, immuno deficiency syndrome, leprosy, malignant disease.
- •5.Patients having known drug allergy of sulphur, mercury.
Outcomes
Primary Outcomes
Cure of Dadru kushta signs and symptoms Kandu (Pruritus)
Time Frame: 2 months
Raga (Erythema)
Time Frame: 2 months
Number of Mandala
Time Frame: 2 months
Size of Mandala
Time Frame: 2 months
Secondary Outcomes
- no recurrence of Dadru(4 weeks)
Investigators
Study Sites (2)
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