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临床试验/CTRI/2025/03/081681
CTRI/2025/03/081681尚未招募2/3 期

To study the efficacy of guduchyadi kashaya with vidangadi lepa in comparison with patoladi kashaya with vidangadi lepa in vicharchika atopic dermatitis :A controlled randomized clinical study

Dr Prashanth S U1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年3月5日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
area and severity index)

研究概览

简要总结

A Controlled clinical study on the efficacy of Guducyadi kashaya in the management of Vicharchika (Atopic dermatitis) in adults of age group 18-60 years for a period of 30 days. During this study period 30 subjects diagnosed with Vicharchika (Atopic dermatitis) will be recruited and divided into two groups, Group A (Trial drug/Intervention group) and Group B (Control drug/Comparator group) 15 subjects in each group respectively. Group A (Trial drug/Intervention group) it includes 15 subjects qualifying inclusion criteria of the current study will be administered Guducyadi kashaya internally  in the dose of 50ml in the morning and Night 20mins before food followed by ushnajala pana along with Vidangadi lepa as an external application for 30days starting from day-01 of trial, assessment of the patient during trial on Oth day(baseline), 15th day, 30th day and after trial on 45th day.  Group B (Control Drug/Comparator Group) it includes 15 subjects qualifying inclusion criteria of the current study will be administered Patoladi kashaya internally  in the dose of 50ml in the morning and Night 20mins before food followed by ushnajala pana along with Vidangadi lepa as an external application for 30days starting from day-01 of trial, assessment of the patient during trial on Oth day(baseline), 15th day, 30th day and after trial on 45th day. The primary outcome measure will be significant improvement noticed in signs and symptoms of Vicharchika through EASI SCALE (Eczema area and severity index)  after 30 days. The secondary outcome measure will be improvement noticed in Kandu (itching) • Daha (burning sensation) • Atiruja (severe pain) • Rukshata (dryness) • Shyava varna (discoluration) after 30 days. Statistical analysis will be done through data obtained based on, before and after treatment assessment

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • 1.Patients between the age of 20 and 60 years with irrespective of sex, religion and socioeconomic status
  • Duration of disease less than 10 years
  • Patient diagnosed as vicharchika on basis of lakshanas like kandu, atiruja, daha, shyava, rukshata.
  • Patients with the signs and symptoms of atopic dermatitis 5.Patients who are ready to give their consent.

排除标准

  • 1.Patient age below 20 and Above 60 years
  • Patient diagonsed with Uncontrolled diabetes mellitus, HBsAG positive, uncontrolled hypertension.
  • Other dermatitis like wet eczema, contact dermatitis, dyshidrotic eczema, neurodermatitis, nummular eczema, stasis dermatitis, seborrheic dermatitis 4.Alcohol and drug abuse 5.Pregnant and lactating women.

结局指标

主要结局

area and severity index)

时间窗: 0th day (Baseline), 15th day, 30th day and 45th day

Improvement noticed in signs and symptoms of Vicharchika through EASI SCALE (Eczema

时间窗: 0th day (Baseline), 15th day, 30th day and 45th day

次要结局

  • Improvement noticed in(. Kandu (itching))

研究者

发起方
Dr Prashanth S U
申办方类型
Other [[self ]]
责任方
Principal Investigator
主要研究者

Dr Prashanth S U

Shri Dharmasthala Manjunatheswara Institute of Ayurveda and Hospital , Bangalore

研究点 (1)

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