Efficay of Traditional Ayurvedic Formulation (Divya Phyter) in patients with Functional Constipation: A single-arm, open-label, observational study.

Patanjali Research Institute governed by Patanjali Research Foundation Trust, Haridwar Uttarakhand0 个研究点目标入组 207 人开始时间: 待定最近更新: 2024年1月22日

试验速览

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•1. Male and female subjects aged greater than or equal to 18 years.
•2. Subjects fulfilling greater than or equal to two on Rome IV diagnostic criteria for Functional Constipation
•3. Non-pregnant and non-lactating female subjects.
•4. Signed informed consent for study-specific procedures.
•5. Availability and willingness to complete all study visits and procedures per protocol.

•1. Patients who were on medications known to cause constipation (like opioid analgesics, antidepressants, i.e., amitriptyline and imipramine, anticonvulsants, and aluminium-containing antacids).
•2. Patients with a history of abdominal or anorectal surgery in the past one year and those with renal or liver dysfunction or colonic inertia or structural abnormalities of the gastrointestinal tract or uncontrolled systemic ailments (like Human immunodeficiency virus and Tuberculosis) or neurological problems (like Parkinson’s disease, multiple sclerosis, sacral nerve damage, and paraplegia or autonomic neuropathy).
•3. Functional gastrointestinal disorders other than Functional constipation (i.e., IBS, GERD etc.)
•4. Pregnancy or breastfeeding.
•5. Known hypersensitivity to any excipients of the intervention.
•6. Inability to fully comprehend and/or perform study procedures or provide written consent in the Investigator’s opinion.
•7. Any other medical condition that, in the opinion of the investigator, makes the patient incompetent to participate in the trial or places the patient at potential risk, e.g. any chronic comorbidity.

发起方

Patanjali Research Institute governed by Patanjali Research Foundation Trust, Haridwar Uttarakhand