Health Condition 1: K63- Other diseases of intestine
Conditions
Interventions
None listed
Sponsors
Pankajakasthuri Herbals India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: i. Subjects willing and able to provide signed informed consent prior to any study related to procedure. ii. Subjects of either sex in the age group between 18 to 60 years. iii. Participants with a confirmed diagnosis of constipation, defined as fewer than 3 bowel movements per week, or a history of straining, hard stools, or incomplete evacuation. iv. Participants who have used laxatives in the past, but have not used them in the 2 weeks prior to study entry.
Exclusion criteria
Exclusion criteria: i. Women who are pregnant, lactating or planning to become pregnant during the study period. ii Subjects with severe constipation, defined as fewer than 1 bowel movement per week. iii. Subjects with symptoms of acute abdomen and intestinal obstruction. iv. Subjects with a history of gastrointestinal conditions such as inflammatory bowel disease, tumours, gastrointestinal obstruction or gastrointestinal surgery. v. Subjects with known hypersensitivity to ingredients of the trial drug. vi. Subjects with History of Diabetes mellitus, hypertension, immunodeficiency or any illnesses that may be worsened by participation in the trial. vii. Patients who, during the previous week, had ingested any drug that, in the opinion of the investigator, would have an effect on gastrointestinal motility viii. Subjects with history of alcohol or drug abuse. ix. Subjects participating in any other clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Frequency of Bowel movement per day 2.Consistency of bowel. 3.Subjective criteria (bloating, straining, incomplete evacuation). Timepoint: Evaluation will be done on baseline (ie; 0th day), 7th day, 14th day, 21st day and 28th day (end of treatment). And follow-up 1 week post treatment (35th day). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Blood routine, LFT and RFT will be done to evaluate the safety of the trial drug before (0th day) and after the treatment (28th day). 2. Reporting and assessment of Adverse reactions / side effects if any. Adverse events, such as cramping and diarrhoea will be carefully monitored throughout the study. Timepoint: valuation will be done on baseline (ie; 0th day and after the treatment (28th day). | — |
Countries
India
Contacts
Public ContactDr Kasthuri Nair A
Pankajakasthuri Ayurveda Medical college and PG centre
Outcome results
None listed