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临床试验/CTRI/2025/02/080068
CTRI/2025/02/080068招募中2 期

Clnical Study to Evaluate the Efficacy of Bhedana with Katuki Followed by Mukhadhooshikaharalepa in Acne.

未提供1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2025年2月17日最近更新:

试验速览

阶段
2 期
状态
招募中
入组人数
35
试验地点
1
主要终点
Understanding Youvanapidaka in modern perspective.

研究概览

简要总结

CLINICAL STUDY TO EVALUATE THE EFFICACY OF BHEDANA WITH KATUKI FOLLOWED BY MUKHADHOOSHIKAHARA LEPA IN ACNE.

 Akhil J1, Dr Arjun Chand2, Dr Aparna Chandran3

Acne, a common skin condition, manifests as various types of blemishes on the skin, predominantly occurring during adolescence but can persist into adulthood for some individuals. It typically arises when hair follicles become clogged with oil and dead skin cells, leading to the formation of pimples, blackheads, whiteheads, or cysts. The primary culprit behind acne development is often an overproduction of sebum, an oily substance produced by the skin’s sebaceous glands. This excess oil, combined with bacteria and dead skin cells, creates an ideal environment for inflammation and the subsequent appearance of acne lesions.

Youvanapidaka, refers to a specific type of skin condition characterized by the formation of stubborn, deepseated pimples or boils on the face. These eruptions are often painful and can leave behind scars if not properly managed. It’s one among the Kshudrarogas told by Acharya Sushrutha in Kshudraroga Pratisheda on Sushrutha Samhitha. Youvanapidaka is primarily caused by an imbalance in the body’s doshas, specifically the aggravation of Pitta and Kapha doshas. Pitta, responsible for digestion and metabolism when disturbed, leads to the accumulation of toxins (ama) in the body, which manifest as skin issues like Youvanapidaka. Kapha imbalance contributes to excess oil production and blockage of skin pores, further exacerbating the condition. Further Dosha dooshya sammurchana in the Raktavahasrotas of face which leads to Pidaka Utpatti is the main pathology. Such a condition needed to be managed with Laghu, Rooksha, Tikshna, Kaphapitta shamaka, Twachya and Krimihara Dravya. Hence the formulation named Mukhadooshikahara Lepa with above mentioned qualities is selected for the study.

This study is proposed as Interventional clinical study with pre and post-test. Subjects   irrespective of gender at the age group of 18-40 years registered in the OP Department of Kayachikitsa, Pankajakasthuri Ayurveda Medical College Hospital, Kattakada, Thiruvananthapuram, satisfying the inclusion criteria will be selected for the study. Subjects will be consecutively selected into the study till attaining the sample size of 35. The necessary data will be collected through observation, examination and history taking. Then the data will be recorded using case record form.

Subjects will be advised Katuki Churna 2g with warm water on the 0th day night bed time and from the next day Mukhadooshikahara Lepa mixed with water is to be applied externally over acne in 3mm thickness for 14 days. Assessment will be done on 0thday, 8th day, 15thday and 30th day using objective parameters. Changes will be compared using Plewig and Kligmann Acne Assessment scale. The results will be analyzed statistically and conclusions will be drawn

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 40.00 Year(s)(—)
性别
All

入选标准

  • Subjects of age group 18-40 years irrespective of their gender and socio-economic status.
  • Subjects selected using Clinical diagnosis of Acne based on ICD 10 L70.9 of Inflammatory Papules, pustules, Nodules.
  • Non-inflammatory-Open and closed Comedones.
  • Subjects with recurrent Acne since one month.
  • Subjects willing to provide written informed consent.

排除标准

  • Subjects with Acne induced due to androgenic steroids, anti-convalescents, Corticosteroids, Anti-epileptics, Antidepressants, Rifampicin, Isoniazid.
  • will be excluded from the study.
  • Subjects with skin issues other than Acne.
  • Subjects with active phase of Diabetic carbuncles, Chickenpox.
  • Subjects who are contraindicated for Virechana v.
  • Pregnant ladies and lactating mother.

结局指标

主要结局

Understanding Youvanapidaka in modern perspective.

时间窗: Assessment will be done on the 0th, 8th, 15th and 30th day

To evaluate the effectiveness of Bhedana with Katuki followed by Mukhadooshikahara Lepa in the management of Acne.

时间窗: Assessment will be done on the 0th, 8th, 15th and 30th day

1.Global Acne Grading System (GAGS).

时间窗: Assessment will be done on the 0th, 8th, 15th and 30th day

2.Plewig And Kligmann Acne Assessment Scale.

时间窗: Assessment will be done on the 0th, 8th, 15th and 30th day

3.Blood routine with Erythrocyte Sedimentation Rate

时间窗: Assessment will be done on the 0th, 8th, 15th and 30th day

4.Random Blood Sugar

时间窗: Assessment will be done on the 0th, 8th, 15th and 30th day

5.Absolute Eosinophil count

时间窗: Assessment will be done on the 0th, 8th, 15th and 30th day

6.Renal Function test

时间窗: Assessment will be done on the 0th, 8th, 15th and 30th day

7.Liver Function test

时间窗: Assessment will be done on the 0th, 8th, 15th and 30th day

8.Contact Allergy Test

时间窗: Assessment will be done on the 0th, 8th, 15th and 30th day

次要结局

  • NOT APPLICABLE(NOT APPLICABLE)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Arjun Chand C P

Pankajakasthuri Ayurveda Medical College & Pg Centre Killi Kattakada Thiruvananthapuram

研究点 (1)

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