The Efficacy of Individualized Homoeopathic Medicines in Centesimal Potency in the Treatment of Chronic Functional Constipation in Adults: A Double-Blind, Randomized, Placebo-Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Symptoms (PAC-SYM) questionnaire
研究概览
简要总结
Constipation is defined as infrequent passage of hard stools. Patients may also complain of straining, a sensation of incomplete evacuation and either perianal or abdominal discomfort. Constipation can be acute typically lasting less than 1 week, or chronic, lasting greater than 4 weeks. Chronic constipation is normally due to a primary cause, such as dietary intake (e.g. insufficient fiber), lifestyle factors (e.g. sedentary lifestyle) or disorders of rectal evacuation. Secondary causes of chronic constipation are numerous, including drugs such as opiates. The average prevalence of constipation in adults has been estimated as 16% worldwide (varies between 0.7% and 79%). There is quite lack of data available in homoeopathy in treatment of constipation. Keeping in view this lack of validated clinical trial on Chronic Functional Constipation, we aimed to evaluate effects of homoeopathic medicines beyond placebo by conducting this 3-months Double-Blind, Randomized(1:1), Placebo-Controlled Trial of individualized homeopathic medicines in centesimal potency against placebo at The Calcutta Homoeopathic Medical College & Hospital on 140 participants with chronic function constipation in adults.
For Primary outcome assessment The Patient Assessment of Constipation Symptoms (PAC - SYM) questionnaire is administered, and for secondary outcome assessment The Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire is taken.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients of 18-65 years age
- •The diagnosis of chronic functional constipation was based on the Rome IV Diagnostic Questionnaire (R4DQ) criteria for adults [Appendix- 2B] which were fulfilled for the past 3 months with symptoms onset at least 6 months before diagnosis.
- •ICD-10 code K59.04 for Chronic idiopathic constipation (functional constipation)
- •Illiterate people will be interviewed by the investigators maintaining adequate privacy to fill up the scales or questionnaires
- •Literate participant able to read and write in English, hindi or bengali
- •Participants providing with written informed consent.
排除标准
- •Criteria for irritable bowel syndrome or OIC fulfilled as per R4DQ for adults.
- •Patients taking concomitant medications which may modify bowel habits.
- •Diagnosed case of Inflammatory Bowel Disease (IBD).
- •Has a history of structural abnormality of the Gastrointestinal (GI) tract or a disease or condition that can affect GI motility.
- •Unstable mental or psychiatric illness or other systemic diseases ( e.g., uncontrolled hypertension, diabetes, thyroid diseases etc.) affecting quality of life or any vital organ failure
- •Any substance abuse
- •Self-reported immune – compromised state
- •Pregnant and puerperal women, and lactating mothers.
- •Patients who are too sick for consultation
- •Simultaneous participation of any other clinical trials.
结局指标
主要结局
Symptoms (PAC-SYM) questionnaire
时间窗: At baseline, every two weekly, up to three months
The Patient Assessment of Constipation
时间窗: At baseline, every two weekly, up to three months
次要结局
- The Patient Assessment of Constipation Quality of(Life (PAC-QOL) questionnaire)