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临床试验/CTRI/2023/08/057153
CTRI/2023/08/057153尚未招募2/3 期

A comparative study on efficacy of Durnamhara Lepa and Shigrumoolaadi Lepa in Arsha Roga

Shri Krishna Govt Ayurvedic College and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年1月9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
60
试验地点
1
主要终点
To assess the comparative efficacy of Durnamahara Lepa & Shigrumooladi Lepa in Arsha Roga.

研究概览

简要总结

Arsha (Haemorrhoids) is a clinical condition involving ano-rectal region in which structural

derangement take place. During process of pathogenesis, theDoÅŸhas are vitiated due to indulgence

in etiological factors by the person that in turn leads toAgnimandya that further hampers the

functions of Apana vayu. These vitiatedDoshas get localized in the Mamsa and Meda of guda pradesha, which result intoappearance of Mamsa prarohas or Arsha. Acharya Sushruta placed thisdisorder in the “Ashta Mahagadaâ€. A lepa is the initial treatment which iscommon to all inflammatory swellings. A lepa not only relives pain andswellings, it also alleviates dosha, causes shodhana and helps to in healing process.In my study there is two lepa i.e. Durnamhara lepa and Shigrumooladi lepa.Durnamhara lepa contains kadvi tumbi(Lagenaria Vulgaris) and guda(Jaggery).Whereas Shigrumooladi lepa contains Shigru(Moringa Olifera) andArka(Calotropis gigantea). These drugs possess Katu and Tikata Rasa, KatuVipaka, Ushana Virya, which may acts as Chedana on Arsha roga. Total60 patients will be randomly selected for the study, with ages ranging

from 16 years to 65 years, irrespective of gender, religion,occupation, socio- economic status etc. Duration of Treatment : Theduration of treatment for Group-1 and Group-2 patients istaken for 14 days. The therapeutic effects will be analyzed byusing the subjective parameters viz. pain and itching  and objective paramaters viz, number&size of pile mass, BPR (bleeding per rectum), prolapse etc. Follow-up:-Patientswill be called, once after a week i.e. on 21st day. Then two times on monthly  basis i.e. on 51th day and 81thday; in 3 sittings.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

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

入选标准

  • 1.Patients with age group of 16-65 yrs.
  • 2.Patients with 2nd and 3rd degree internal piles.
  • 3.Patients who are willing to give consent for treatment.

排除标准

  • Patients with age group of less than 16yrs and more than 65 yrs.
  • Pregnant females.
  • Patients with malignancy.
  • Patients with rectal prolapsed.
  • Patients with 1st and 4th degree hemorrhoides.
  • Patients having hemorrhoides associated with fissure and fistula in ano.
  • Patients having hepatitis B , TB, HIV positive cases.
  • Acute and Chronic anal fissure.
  • 9.Uncontrolled hypertension and DM.

结局指标

主要结局

To assess the comparative efficacy of Durnamahara Lepa & Shigrumooladi Lepa in Arsha Roga.

时间窗: Duration of the treatment- It will be given for 14 days. | Route of administration- Local application. | Dose- according to pile mass. | Follow up- it will be done after 7 days.

次要结局

  • 1. To assess the role of Durnamahara Lepa in management of Arsha Roga.(2. To assess the role of Shigrumooladi Lepa in management of Arsha roga.)

研究者

发起方
Shri Krishna Govt Ayurvedic College and Hospital
申办方类型
Government medical college

研究点 (1)

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