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临床试验/CTRI/2025/02/081374
CTRI/2025/02/081374尚未招募3 期

A RANDOMIZED COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF SHADAV CHURNA AND BHUNIMBADI CHURNA IN MANAGEMENT OF GRAHANI VYADHI WITH SPECIAL REFERENCE TO IRRITABLE BOWEL SYNDROME.

Dr Lajja Mangrola1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月7日最近更新:

试验速览

阶段
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
Reduction in sign and symptoms of Grahani vyadhi

研究概览

简要总结

Introduction:Grahani dosha described in classical text books of Ayurveda represents a group of disorders of digestive system caused by impairment of Agni. The cardinal features of Grahani dosha explained in the classical text books of Ayurveda, have at most similarities with the clinical features of Irritable Bowel Syndrome (IBS) as described in contemporary medicine.This is one of the common clinical problems among patients attending gastroenterology clinics. The main clinical features of this ailment are abdominal pain associated with an altered bowel habit (may present with diarrhoea or constipation or intermittently both) in the absence of any structural pathology.

A Randomized Comparative Clinical Study to Evaluate the Efficacy of Shadav Churna and Bhunimbadi Churna in the Management of Grahani with Special Reference to Irritable Bowel Syndrome will be conducted as a randomized comparative clinical trial. A total of 60 participants will be enrolled and randomly divided into two groups: Group A (Trial Group) and Group B (Control Group), with 30 participants in each group. Group A will receive Shadav Churna, while Group B will be administered Bhunimbadi Churna. Both groups will receive a dose of 4 grams thrice daily (TDS) with Koshna Jala (warm water) as an Anupana . The route of administration will be oral, and the total duration of the treatment will be 28 days. The primary objective of this research will be to evaluate and compare the efficacy of Shadav Churna and Bhunimbadi Churna in the management of Grahani (Irritable Bowel Syndrome), thereby contributing to the scientific validation of these Ayurvedic formulations.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • Clinically diagnosed patients fulfilling the subjective criteria of Grahani .
  • Muhur/ Muhur Drava mala pravritti, Udgar, arochaka, balakshaya.
  • Known case of Grahani / IBS.
  • Diagnosis as per ROME IV Criteria for IBS.
  • Patients inclusive of all sex.

排除标准

  • Known case of Active PR Bleeding & GI disease such as Crohn’s disease, Amebiasis, Celiac Disease.
  • History of colon resection.
  • Patient suffering from acute diarrhoea, Intestinal tuberculosis, Gastric and Peptic ulcer, Colitis associated with significant complications like haemorrhage, perforation, stricture, colonic cancer, toxic mega colon.
  • Immunocompromised individuals on immunosuppressive drugs.
  • Pregnant women and lactating mother.

结局指标

主要结局

Reduction in sign and symptoms of Grahani vyadhi

时间窗: 28 days

次要结局

  • Agni Parikshan of patients before and after the treatment.(28 days)

研究者

发起方
Dr Lajja Mangrola
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Lajja Mangrola

Padmashree Dr D Y Patil School of Ayurveda, Nerul, Navi Mumbai

研究点 (1)

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