Comparative Evaluation of Efficacy of Modified form of Sindooradhya Taila (Ointment) vs Vachadi Ointment the management of Scabies (Pama) in school-going children:A Randomized clinical trial
Overview
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Mahatma Gandhi Ayurveda College Hospital and Research Centre
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- To evaluate the efficacy of Sindooradhya ointment in Pama (Scabies) in Children of 5 year to 16 years by gradation scale parameter with number and size of patches
Overview
Brief Summary
the volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod (H) Wardha and CTRI registration will be done. After selection, each participant will be tested individually and selected according to selection criteria. They are divided into two groups the trial is a Randomized standard Control Superiority Clinical Trial. it will include a 14 days treatment period and after 14 days follow-up period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 5.00 Year(s) to 16.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patient willing to give written informed consent with either gender having age of 05 to 16 years and patients Parents willing to allow their child to participate with Clinically diagnosed Pama (Scabies).
Exclusion Criteria
- •Patients who have had a long-term Pama Kushtha infection and with additional skin conditions and Having serious systemic illnesses such as HIV TB systemic lupus erythematosus.
Outcomes
Primary Outcomes
To evaluate the efficacy of Sindooradhya ointment in Pama (Scabies) in Children of 5 year to 16 years by gradation scale parameter with number and size of patches
Time Frame: at 7th, 15th days
Secondary Outcomes
- To evaluate the efficacy of Vachadi ointment in Pama (Scabies) in Children of 5 year to 16 years by gradation scale parameter with number and size of patches(at 1st , 2nd week)
Investigators
Dr Tushar Subhash Nandanwar
Mahatma Gadhi Ayurved college Hospital and Research centre