A clinical trial to evaluate the effect of specialized treatment protocol using Takra in the management of Grahani Dosha with special reference to Irritable bowel syndrome
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
- Reduction in signs and symptoms of Grahani Dosha by correcting Agni and Ama
研究概览
简要总结
Introduction:
Grahani dosha described in classical text books of Ayurveda represents a group ofdisorders 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 describedin contemporary medicine. This is one of the common clinical problems among patients attendinggastroenterology clinics. The main clinical features of this ailment are abdominal pain associatedwith an altered bowel habit (may present with diarrhoea or constipation or intermittently both) inthe absence of any structural pathology . And the management of this disease is having limitationsin the present scenario of the contemporary science. All acharyas highlighted in classical texts which are Laghutrayi’s and Bruhatrayi’s, whichpossess Deepana, Grahi & Laghu Gunasv. Due to Swadu-amla rasa, Sandra-avidahi guna itpacifies Vata Dosha, due to Madhur Vipaka it pacifies Pitta dosha, due Kashay rasa, Ushna andVikashi and Ruksha it pacifies Kapha dosha. So, by looking efficacy of Takra in Grahani whichis useful in practice.
Objective:
Primary objective – Reduction in signs and symptoms of Grahani Dosha by correcting Agni and Ama.
Secondary objective – To improve the quality of life.- Nutritional assessment before and after treatment of patient.
Methodology:
Study type: Interventional
clinical studyDesign: Pre-test and Post-test design
Allocation: Single arm
Masking: Open label
Primary Purpose: Treatment
Sample size: 30
Group intervention:
Dadimastakachurna 6gm with 100 ml of Takra
Balbilwa Churna 3gm and Musta Churna 6 gm with 100 ml Takra
Panchasakara Churna with wam water
Duration: 30 days
Followup: 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients irrespective of sex, religion, occupation will be selected for study.
- •Patients having pratyatma lakshana of Grahani Dosha especially – Atisrushtam or Ativibadhham or Atidravam malapravritti (altered bowel habits), Trushna, Arochaaka, Vairasya, Praseka, Tamaka, Shoona pada, Shoona kara, Asthi-parva ruja, Chhardi, Jwara, Louha-ama-gandhi tiktamlodgara.
- •The patients who are diagnosed with IBS according to standard ROME IV criteria.
- •Previously diagnosed case of IBS.
- •Able and willing to give written informed consent.
排除标准
- •Mixed infection with parasites such as round worms, hook worms etc.
- •Ulcerative colitis, Crohn’s disease, gastric ulcerations and other inflammatory bowel conditions.
- •Infectious disorders like Intestinal tuberculosis etc.
- •Patients with evidence of malignancy.
- •Patents with diabetes mellitus (FBS >126 mg/dl, PP >200 mg/dl), poorly controlled hypertension, Thyroid disorders and any other autoimmune disorders.
- •Amoebic dysentery, acute diarrhoea.
- •Lactose intolerance patients.
- •Abuse of drug or alcohol.
- •Patients on prolonged medication with NSAIDs, analgesics or any other drugs that may have an influence on the outcome of the study.
- •History of hypersensitivity to any of the trial drugs or their ingredients.
- •Patients who have completed participation in any other clinical trial during the past 6 months which is interfering with the results of Grahani Dosha.
- •All the types of atisara, Antraja krimija patients and any other conditions interfering with the results of Grahani Dosha / IBS.
结局指标
主要结局
Reduction in signs and symptoms of Grahani Dosha by correcting Agni and Ama
时间窗: 0th day, 15th day, 30th day, 60th day
次要结局
- 1. Nutritional assessment of patient before and after the treatment.(2. To Improvement the quality of life.)