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临床试验/CTRI/2025/02/081208
CTRI/2025/02/081208尚未招募不适用

A Randomized Controlled Clinical Trial To Evaluate The Efficacy Of Triphala Mashi Lepa In Agnidagdha Vrana.

Dr.Gouri Vijay Mane.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年3月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
To evaluate the Ropan effect of Triphala Mashi Lepa in Agnidagdh vrana.

研究概览

简要总结

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 -

  1. Patients Age between 18 to 60 years.

  2. Patients irrespective of sex, religion, occupation etc

  3. Patients with 1st and 2nd degree superficial burn.

  4. Patients having up to 5%TBSA (Total body surface area)burn.

  5. Patients having wounds on extremities and trunk only.

  6. Agnidagdh vrana due to heat including dry and moist.

  7. 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.

  1. Patients having more than 5% TBSA (Total body surface area)burn.

  2. Patients with 2nd degree deep burn and above that .

  3. Known case of AIDS, Uncontrolled DM, Hepatitis B., TB and

immunocompromised people.

  1. Electrical, Chemical, Frost and Radiation burn.

  2. Taxemia , Septicemia.

  3. 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.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

To evaluate the Ropan effect of Triphala Mashi Lepa in Agnidagdh vrana.

时间窗: 14 days study with follow up on 5th,10th,15th day

次要结局

  • 1) Literature study of Agnidagdh vrana from Ayurvedic & modern(texts.)

研究者

发起方
Dr.Gouri Vijay Mane.
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Gouri Vijay Mane

MES Ayurved Mahavidyalaya

研究点 (1)

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