Study the effect of Gojivhadi Malahara (Ointment) for the Treatment of Napkin Dermatitis (Ahiputana)

Phase 2/3

Recruiting

• Conditions: Other specified local infections of the skin and subcutaneous tissue. Ayurveda Condition: AHIPUTANA/AHIPUTANAKAH,

• Registration Number: CTRI/2023/02/049832
• Lead Sponsor: Dr Umang Varshney

Brief Summary

This is a single Arm clinical study in which Gojivhadi Malahara will be provided to 38 patients showing signs and symptoms of Ahiputana (Napkin Dermatitis). The age group taken for the study trial will be infants up to 1 year. The mode of drug administration will be by external application in form of malahara. Patients will be examined on first day and follow up on 3rd & 7th day will be taken. Total duration of drug administration for trial will be of 7 days.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-03
• Last Update Posted: 2023-09-27

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• 1)Infants who suffer with Ahiputana.
• 2)Infants age up to 1 year.
• 3)Patients will be selected irrespective of sex and socioeconomic status.
• 4)The Patients whose parents are ready to participate in the clinical trial by giving informed written consent.

Exclusion Criteria

• 1)Infants having other generalized skin infections.
• 2)Infants having life threatening illness.
• 3)Infants who are known case of systemic illness.
• 4)Infants who have other than clinical signs and symptoms of Ahiputana.
• 5)Children above 1 year of age.
• 6)History of Ahiputana more than 10 days.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To decrease kandu(itching) and pidika over perianal region.	7 days study with follow up on 3rd and 7th day(0,3,7)

Secondary Outcome Measures

Name	Time	Method
To Observe the adverse effects , if any	7 days study with follow up on 3rd and 7th day(0,3,7)

Trial Locations

Locations (1)

Dr. D. Y. Patil college of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune; 🇮🇳 Pune, MAHARASHTRA, India

Dr. D. Y. Patil college of Ayurved and Research Centre, Sant Tukaram Nagar, Pimpri, Pune

🇮🇳Pune, MAHARASHTRA, India

Dr Umang Varshney

Principal investigator

7017045253

drumang001@gmail.com