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临床试验/CTRI/2024/11/077493
CTRI/2024/11/077493进行中(未招募)不适用

ROLE OF INDIVIDUALIZED HOMOEOPATHIC MEDICINES IN TREATMENT OF ALOPECIA AREATA IN ADULTS USING KENTS REPERTORY A PRE POST INTERVENTIONAL STUDY

Mahesh Bhattacharyya Homoeopathic Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年12月8日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
40
试验地点
1
主要终点
The Severity of Alopecia Tool (SALT)

研究概览

简要总结

Alopecia areata (AA) is a chronic, immune-mediated autoimmune disorder that affects hair follicles, nails, and, rarely, the retinal pigment epithelium. The classic presentation of AA is isolated, smooth, sudden, non-scarring, and patchy hair loss on the scalp or any area with hair growth. AA targets the anagen hair follicles of individuals and leads to hair loss without permanent damage to the follicles. There is a dearth of evidence-based documentation on this particular subject in homoeopathy. A single-arm pre-post interventional study will be conducted with 40 participants having AA. All the participants will be given individualized homoeopathic medicines. Thye medicines will be procured from GMP certified company and will be dispensed from the dispensory of the hospital (MBHMC&H). The medicines will be administered orally. The medicines’ potency, dose, and repetition will be as per the guidelines of Organon of Medicine. 

The period of enrolment will be 12 months and the duration of follow-up for each patient will be 6 months.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed cases of Alopecia areata (Using Symptoms mainly) The diagnosis of alopecia areata is usually made on clinical grounds and in most cases, further tests are not needed.
  • Affected individuals report hair loss and the abrupt appearance of a hairless area which is circular having standard skin color.
  • Presence of Exclamation mark hair at the periphery of the lesion is pathognomonic.
  • Adult population Aged between 18years to 65 years of all sexes.
  • Patients using topical agents for Alopecia will be included after a washout period of one month.
  • Patients giving written consent to participate.

排除标准

  • Alopecia universalis.
  • Alopecia Totalis.
  • Ophiasis and Sisaipho.
  • Individuals diagnosed with unstable psychiatric illness.
  • Any uncontrolled systemic diseases.
  • Substance abuse and/or dependance.
  • Pregnant and Lactating women.
  • Those treated with any kind of local steroidal injection.
  • Undergoing homoeopathic treatment for any chronic diseases within last 1 month.

结局指标

主要结局

The Severity of Alopecia Tool (SALT)

时间窗: will be assessed at Baseline & after 6 months of treatment.

次要结局

  • Alopecia Areata Quality of Life Questionnaire (AA-QLI)(will be assessed at Baseline & after 6 months of treatment.)
  • Modified Naranjo Criteria for Homoeopathy(MONARCH)(will be assessed after 6 months of treatment.)

研究者

发起方
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr. Anwesha Mondal

Mahesh Bhattacharyya Homoeopathic Medical College and Hospital

研究点 (1)

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