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临床试验/CTRI/2023/01/048790
CTRI/2023/01/048790已完成2/3 期

“A comparative clinical study to assess the role of Pachan given by Paniya Kshar and by Panchakol Churn on the efficacy of Virechana Karma in Yuvanpidika. â€

National Institute Of Ayurveda1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年10月1日最近更新:

试验速览

阶段
2/3 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Right cheek 2

研究概览

简要总结

Acne vulgaris is a chronic inflammatory disease of the pilosebaceous follicles chracterised by comedons, papules,pustules and often scars. Chiefly on cheeks, chin, nose, forehead and upper trunk. Acne tends to appear earlier in female, due to later onset of puberty in males.

In Ayurvediya samhitas, there is a brief description available about Yuvanpidika. Which is a type of  Khudraroga. The early first description of Yuvanpidika is given in Sushrut samhita. In Charak samhita it is not describe as separate Vyadhi but in ‘Tristreshniya adhayaya’ Pidika roga is said to occur as Bahya roga marga ashrita roga (ch.su. 11/47) . Yuvanpidika is described by Acharya Sushruta as a separate  vyadhi in Nidan sthan 13 and Chikitsa sthan 20 under Khudra rogas. Likewise Acharya Madhav and Acharya Vagbhatt have described Yuvanpidika under Khudrarogas and not in separate chapter*. Acharya* Sushrut has mentioned 44*, Acharya Vagbhatt* 36, and Acharya Madhav has quoted 43 Khudra rogas.

“ शालà¥à¤®à¤²à¥€à¤•ंटकाकारापिटिकासरà¥à¤œà¥‹*धना *:*।मेदोगरà¥à¤­à¤¾à¤®à¥à¤–ेयà¥à¤¨à¤¾à¤® ताभà¥à¤¯à¤¾à¤®à¥à¤šà¤®à¥à¤–दूषिका:।।“                  (अ. ह. *उ.  31/5 )

 Acharya Vagbhatt mentions the involvement of Vata, Kapha and Meda in the    development of Yuvanpidika. The involvement of Meda can be considered to show similarity with the involvement of sebum in acne. In Samhita various treatment of Yuvanpidika has been described but all can be concluded in two groups :-

1.Shodhan chikitsa- That is purification of body it includes Vaman,Virechana,

Nasya Karm and Raktmokshana.

2.Saman chikitsa- That is conservative treatment by oral and tropical medicines. It includes Lepa, Upnaha and Kshar Karm.

WORK PLAN: -

A. GROUPING- After the complete examination and investigation, all the 30 patients will be randomly divided into two groups equally (15 patients in each  group) as below

GROUP-A

1. Pachan with Paniya kshar (Apamarg kshar in 1 gm in 36ml water)  dose for initial 5 days in the morning )

 2. Mix Apamarg kshar(1gm) in Goghrit for Snehapan(starting dose 25 ml) in increasing dose till the occurance of Samyak Snehan lakshan

.

3. Sarvang Abhayang & Swedan Will be done on 2nd ,3rd ,4th 5th day of Samyak Snehan and on the day of Virechana.

4. Virechana with Trivritavleha

.                  (dose 40-60gm)

5. Sansarjana Karma according to Shudhi Lakshan.

 GROUP-B

1.Pachan with Panchakol churn (3gm) with lukewarm water  For initial 5 days in the morning.

        2. Snehapan with Goghrit (starting dose 25 ml) in increasing                dose till the occurance of Samyak Snehan lakshan (no any Parkshep dravya added)

        3. Sarvang Abhayang & Swedan Will be done on 2nd ,3rd ,4th 5th day of Samyak Snehan and on the day of Virechana.

4. Virechana with Trivritavleha

(dose 40-60gm)

5.Samsarjana Karma

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
18.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Patients with cardinal symptoms of Yuvanpidika like:- Shalmli kantak aakar pidika, Ruja Yukta , Ghanta, Medogarbhata, toda ,srava.
  • Patients between 18-40 years of age group, irrespective of gender and religion.
  • Individual with mild to moderate symptoms of Aam.
  • 4.Patient who are indicated for Virechana Karma.

排除标准

  • Patients presenting with any serious disease having gross electrolyte imbalance and low BT/CT value.
  • Patients who are unwilling for Virechana Karma.
  • Patient with any systemic disorders like Cardiac problem,Diabetes mellitus, Hypertension, Fever etc.

结局指标

主要结局

Right cheek 2

时间窗: day-0 , day- 5, day- 16th, after 1 month

changes in Global Acne Grading System.

时间窗: day-0 , day- 5, day- 16th, after 1 month

Location Factor

时间窗: day-0 , day- 5, day- 16th, after 1 month

Forehead 2

时间窗: day-0 , day- 5, day- 16th, after 1 month

Left cheek 2

时间窗: day-0 , day- 5, day- 16th, after 1 month

Nose 1

时间窗: day-0 , day- 5, day- 16th, after 1 month

Chest and upper back 3

时间窗: day-0 , day- 5, day- 16th, after 1 month

GAGS-A score of 1-18 is considered mild 19-30 moderate 31-38 severe and 39 very severe.

时间窗: day-0 , day- 5, day- 16th, after 1 month

Chin 1

时间窗: day-0 , day- 5, day- 16th, after 1 month

次要结局

  • Changes in weight, lipid profile, skin lusture,bowel habit.(at the base line day and after completion of trail.)

研究者

申办方类型
Government medical college

研究点 (1)

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