A Randomized Controlled Clinical Trial To Evaluate The Efficacy Of Triphala Mashi Lepa In Agnidagdha Vrana.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- To evaluate the Ropan effect of Triphala Mashi Lepa in Agnidagdh vrana.
Study Overview
Brief Summary
Title - A Randomised Controlled Clinical Trial To Evaluate The Efficacy of Triphala Mashi Lepa In Agnidagdh Vrana.
Null Hypothesis - Triphala Mashi Lepa is not effective in Agnidagdh vrana.
Alternative Hypothesis -Triphala Mashi Lepa is effective in Agnidagdh vrana.
Study design - Simple Randomized Controlled Clinical Trial.
Inclusive Criteria -
-
Patients Age between 18 to 60 years.
-
Patients irrespective of sex, religion, occupation etc
-
Patients with 1st and 2nd degree superficial burn.
-
Patients having up to 5%TBSA (Total body surface area)burn.
-
Patients having wounds on extremities and trunk only.
-
Agnidagdh vrana due to heat including dry and moist.
-
Patients who are willing for trial &ready to give informed consent.
Exclusive Criteria
-1) Age group less than 18 years and more than 60 yrs.
-
Patients having more than 5% TBSA (Total body surface area)burn.
-
Patients with 2nd degree deep burn and above that .
-
Known case of AIDS, Uncontrolled DM, Hepatitis B., TB and
immunocompromised people.
-
Electrical, Chemical, Frost and Radiation burn.
-
Taxemia , Septicemia.
-
Head, Neck, Genital Organs.
Sample size - Total 50 (25 for each group).
Patient coming in OPD and IPD of Shalyatantra department of our hospital with complaints of thermal burn .Simple randomized sampling ( Lottery Method) .
Group A - Triphala Mashi Lepa .
Group B - Silver Sulphadiazine local application.
Total duration of drug administration is 14 days.The mode of drug administration will be by local application.
Follow up - Follow up will be done on 5th,10th,15th day.
Result - Result will be drawn as per assessment criteria and statistical analysis.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients Age between 18 to 60 years.
- •Patients irrespective of sex, religion, occupation etc 3) Patients with 1st and 2nd degree superficial burn.
- •Patients having up to 5%TBSA (Total body surface area)burn.
- •Patients having wounds on extremities and trunk only.
- •Agnidagdh vrana due to heat including dry and moist.
- •Patients who are willing for trial &ready to give informed consent.
Exclusion Criteria
- •Age group less than 18 years and more than 60 yrs.
- •Patients having more than 5% TBSA (Total body surface area)burn.
- •Known case of AIDS, Uncontrolled DM, Hepatitis B., TB and immunocompromised people.
- •Electrical, Chemical, Frost and Radiation burn.
- •Taxemia , Septicemia.
- •Head, Neck, Genital Organs.
Outcomes
Primary Outcomes
To evaluate the Ropan effect of Triphala Mashi Lepa in Agnidagdh vrana.
Time Frame: 14 days study with follow up on 5th,10th,15th day
Secondary Outcomes
- 1) Literature study of Agnidagdh vrana from Ayurvedic & modern(texts.)
Investigators
Dr Gouri Vijay Mane
MES Ayurved Mahavidyalaya