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临床试验/CTRI/2019/12/022529
CTRI/2019/12/022529尚未招募2 期

A Comparative Clinical Study on Effect of Shweta Chandanadi Lepa and Kinsukadi Tailam In Twak pratyurjata W.S.R to Cosmetic Induced Skin Allergy

National Institute of Ayurveda1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2020年1月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
45
试验地点
1
主要终点
Skin Allergy

研究概览

简要总结

The study is a Randomized comparative clinical and open-label study to compare the effect of the Shweta chandanadi lep and s Kinshukadi Tailam in cosmetic induce skin allergy.

Grouping for Clinical Study**:** 90 clinically diagnosed and registered patient of Cosmetic induced skin allergy will be divided randomly into two groups. Each group will have 45 patients.

                        GROUP A**:** 45 clinically diagnosed and registered patient of skinallergy will be treated by local application of Shweta chandanadi lepa and internal use of Manjisthadi kwath

Duration – 2 month

Dose –    1.    Lepa once daily for 2 month with honey

2*.*40 ml  Kwath twice daily

GROUP B: 45 clinically diagnosed and registered patient of skin allergy will be treated  by local application of Kinshukadi Tailam and internal use of Manjisthadi kwath

Duration –      2   month

Dose – 1.       40 ml/ week oil for external application

  1.       40 ml Kwath twice daily

FOLLOW UP

Follow up of the patients will be taken at every 15 days interval for 60 days i.e. 1st day, 15 days, 30 days, 45 days and 60 days of study.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
20.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.All patients having complaint skin allergy due to use of any cosmetics and of clinical features like redness itching, urticaria, rashes will be selected for this clinical trial.
  • 2.Patients of age group 20-70 years of either gender visiting the OPD and willing to provide written, informed consent will be selected to the study on basis of specially prepared Performa including relevant parameters.
  • 3.Patients will be selected randomly, irrespective of gender, economical, educational and marital status.
  • 4.Patient ready to give written informed consent.

排除标准

  • ➢Patients not ready to give an informed consent.
  • ➢Patients who have been diagnosed to have local disease like burn, psoriasis leucoderma, leprosy, herpes, measles.
  • ➢Patients suffering from any kind of Malignancy, Diabetes, Cardiac disorder, HIV etc.
  • ➢Patients who are on steroids or there is history of prolonged steroid use or chemo-therapeutic agents.

结局指标

主要结局

Skin Allergy

时间窗: 3 Month ,15 day

次要结局

  • Contact dermatitis(6 Month)

研究者

申办方类型
Government medical college

研究点 (1)

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