Clinical trial to evaluate the role of Jyotishmati taila in the management of Sidhma Kushta (Tinea versicolor)

Phase 3

Completed

Conditions: Pityriasis versicolor. Ayurveda Condition: SIDHMAH,

Registration Number: CTRI/2023/08/056784

Lead Sponsor: Muniyal institute of ayurved

Brief Summary: A RANDOMIZED CONTROLLED CLINICAL TRIALTO EVALUATE THE ROLE OF JYOTISHMATI TAILA IN THE MANAGEMENT OF SIDHMA KUSHTA VIS-Ã€-VIS PITYRIASIS VERSICOLOR

*J**yotishmatitaila* is one of the classical preparation mentionedin Ashtanga Hridaya for *Sidhmakushta*. It contains alkaline water of *Apamarga* (*Achyranthes aspera*)and oil extracted seeds of *Celastrus paniculatus.* Various studies showsthat this oil is having antioxidant, antibacterial, antifungal andhypolipidemic properties and foundhighly significant in tissue epithlialization.The oilin combination with *Apamarga Kshara* is known to have *Kapha hara*action and *Sidhma nashaka*. But the efficacy of the formulation is notdocumented. Hence effort has been made to evaluate the efficacy of topicalapplication of *Jyotishmati Taila* in the management of *Sidhma kushta*.

In this study 40 subjects, 20 in each group will be selected as per inclusion and exclusion criteria.

Group A (study group) - 20 subjects will be subjected to externalapplication of *Jyotishmati taila* over the affected part and retained forminimum 30 minutes Dose: Twice daily(Morning and Night) q.s to cover affected site Duration: 30 days.

Group B (control group) - 20 subjects will be subjected to externalapplication of *Gandakadi lepa* over the affected part and retained forminimum 30 minutes Dose: Twice daily(Morning and Night) q.s to cover affected site Duration: 30 days.

Treatmentperiod: 30 days (Clinical assessmentwill be done on 15thand 30th day of treatment)

Follow up Period: Will be on 45th & 60thday of the treatment.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

Inclusion Criteria

Patients with classical signs and symptoms of Sidhma Kushta 2.
Patients with positive KOH test for fungal dermatophytes 3.
Patients belonging to either gender will be included 4.
Persons willing to participate in the study.

Exclusion Criteria

1.Pregnancy and lactation 2.Patients having P.versicolor with lacerated wounds and associated with secondary bacterial infections and major skin problems 3.Patients suffering from uncontrolled systemic disorders which worsen the conditions ( eg: DM, HIV etc ) 4.Patients presenting with hypopigmentary disorders of skin other than Pityriasis versicolor 5.Patches caused due to burns, chemical explosion etc.
6.Patients who are on topical & systemic antifungal therapy for the same problem.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To reduce the itching	7 days

Secondary Outcome Measures

Name	Time	Method
To minimize the scaly flakes & patch size	30 days

Trial Locations

Locations (1): MUNIYAL INSTITUTE OF AYURVEDA MEDICAL SCIENCES
🇮🇳
Udupi, KARNATAKA, India
MUNIYAL INSTITUTE OF AYURVEDA MEDICAL SCIENCES
🇮🇳Udupi, KARNATAKA, India
DR SUDESH K S
Principal investigator
9686453173
Sudeshsukumar98@gmail.com