A Single blind, Randomized, Parallel group study to compare efficacy and safety of Unani Medicine Kit formulation– Qurs Mulaiyin with Dulcolax in patients with Daimi Qabz(Chronic Constipation)

Central Council for Research in Unani Medicine (CCRUM), New Delhi0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年10月16日

试验速览

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•1. Participants of either sex in the age group 18 to 65 years.
•2. Patients meeting the Rome III diagnostic criteria for functional constipation which were fulfilled for the past 3 months with symptoms onset at least 6 months before diagnosis:
•Must include two or more of the following:
•a. Straining during at least 25% of defecations
•b. Lumpy or hard stool in at least 25% of defecations
•c. Sensation of incomplete evacuation for at least 25% of defecations
•d. Sensation of anorectal obstruction/blockage for at least 25% of defecations
•e. Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor)
•f. Fewer than three defecations per week
•2. Loose stool being rarely present without the use of laxatives
•3. Insufficient criteria for irritable bowel syndrome.

•1. Patients on chronic laxative medication ( >60 days) and/or who were on medications known to cause constipation (like opioid analgesics, antidepressants, anticonvulsants) were excluded.
•2. Known case of a megacolon/megarectum.
•3. Known cases of HIV/AIDS, cancer, etc.
•4. Known cases of other clinically significant co-morbid conditions (severe hepatic, renal, cardiovascular disorders, etc.) that in the opinion of the investigator could affect the efficacy and safety outcome of the study.
•5. Known hypersensitivity to study drug or any of its ingredients
•6. Pregnant and Lactating females
•7. Uncontrolled Diabetes Mellitus
•8. Any systemic disorder requiring prolonged treatment.

发起方

Central Council for Research in Unani Medicine (CCRUM), New Delhi