A randomized clinical study to evaluate the efficacy of bhunimbadi churna with gudambu in the management of grahani roga w.s.r to irritable bowel syndrome.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in the clinical symptoms of ‘Grahani Roga’ (Ch chi 15/53)-
研究概览
简要总结
The primary purpose of this protocol is to evaluate the efficacy of Bhunimbadi Churna with Gurambu in the management of Grahani Roga (Irritable Bowel Syndrome). The study aims to assess whether this Ayurvedic formulation can provide significant relief in GRAHANI Roga w.s.r. To IBS symptoms, improve digestive health, and enhance the quality of life for affected individuals
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 16.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients willing to sign the consent form for trial.
- •2.The patients aged between 16 to 70 years will be selected.
- •3.The patients having clinical signs and symptoms of Grahani and I.B.S. as per Rome 3rd criteria.
排除标准
- •1.Mixed infection with parasites like round worms, hook worms etc.
- •2.Patients with bleeding per Rectum.
- •3.Patients with evidence of malignancy.
- •4.Patients having concomitant illness like HTN, DM, Amoebic dysentery,Ulcerative colitis, Malabsorption syndrome, Inflammatory Bowel Diseases and Intestinal tuberculosis, Lactase deficiency diarrhoea.
- •5.Patients suffering from major systemic illness with corticosteroids, antidepressants, anticholinergics, or any other drugs that may have an influence on the outcome of the study.
- •6.Alcoholics and drug abusers.
- •7.Pregnant or lactating women.
- •8.Patients who have completed participation in any other clinical trial during the past six months.
结局指标
主要结局
Change in the clinical symptoms of ‘Grahani Roga’ (Ch chi 15/53)-
时间窗: 2 WEEKS
1) Atisarusht or vibaddham drava mala (Diarrhoea or Constipation )
时间窗: 2 WEEKS
2) Trishna ( excess thirst)
时间窗: 2 WEEKS
3) Arochak (anorexia)
时间窗: 2 WEEKS
4) praseka (excessive salivation)
时间窗: 2 WEEKS
5) Lohaamgandhistiktamla udgarshch (belching eructation having metabolic smell, smell of ama and bitter and sour tastes.
时间窗: 2 WEEKS
次要结局
- 1. Change in the objective parameters.(2. Change in Hamilton Depression Rating Scale.)
研究者
Virendra Singh
Keshav ayurved medical college and hospital aklera jhalawar rajasthan