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临床试验/CTRI/2025/03/081545
CTRI/2025/03/081545尚未招募2/3 期

The Effect of Tri-Arm Ayurvedic Intervention on Functional Constipation - A Randomized Clinical Trial

GJ Patel Institute of Ayurvedic Studies and Research Center1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年3月4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
120
试验地点
1
主要终点
Changes in the symptoms of functional constipation (Rome IV Criteria)

研究概览

简要总结

Functional constipation is a prevalent chronic condition among older individuals. The pathophysiology of functional constipation is multifactorial and includes diet, colonic motility as well as absorption, anorectal motor and sensory function, and behavioral as well as psychological factors. It negatively impacts health-related quality of life and economic burdens. After ample research, still patients are dissatisfied with their symptom improvement, adverse effects, and inconvenience. This study of local treatment will help to minimize the dissatisfaction of the patient with present therapies. In the present study, a total of 120 (40 in each group) incidentally enrolled patients with Functional constipation diagnosed with Rome IV criteria will be allotted to any one group among three with a computerized randomization method. This randomized clinical trial aimed to evaluate the efficacy of Bindu ghrita local application on the umbilicus, Trikatvadi varti per rectal administration, and Trivritta churna orally on functional constipation. Patients will be treated for 3 weeks, in the first week with daily medicine, in the second week with alternate-day medicine, and in the third week without medicine in follow-up. Patients who have more than 3 motions/day will be excluded from the study. Patients having constipation for more than 3 days with medicine will be excluded from the study and will be given rescue medicine. Assessment will be done with Rome IV criteria and the question of PAC-QOL. At the end of the trial, data will be collected and subjected to appropriate statistical analysis, and a final conclusion will be framed.

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
30.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Study participants of both genders and age group 30 to 60 years with Functional constipation defined according to the Rome IV criteria and able to understand the procedure, will be eligible for inclusion in the study.
  • Patients suffering from functional constipation and eligible for inclusion in the study will be advised to refer to protocol details.
  • Patients ready to stop taking the previous medications for constipation.
  • Their voluntary participation will be confirmed by signing the informed consent.
  • The objectives, potential benefits and risks of the research will be explained to them.

排除标准

  • Patients suffering from secondary constipation Patients with a diagnosis or history of obstructive ileus Suspected/confirmed diagnosis of irritable colon syndrome, ulcerative colitis, Crohn’s disease or malignant digestive tract disease Taking opioid analgesic and antidepressants Pregnant and lactating women Known cases of uncontrolled Diabetes mellitus, HIV, TB, Thyroid disorders etc.

结局指标

主要结局

Changes in the symptoms of functional constipation (Rome IV Criteria)

时间窗: 21 days

次要结局

  • Patients Assessment of Constipation-Quality of life (PAC-QOL)questionnaire(21 days)

研究者

发起方
GJ Patel Institute of Ayurvedic Studies and Research Center
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Indrodiya Hemaxi

Department of Kayachikitsa

研究点 (1)

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