CTRI/2024/05/068120
Not yet recruiting
Phase 2
An open-label randomized controlled clinical study to compare the efficacy and safety of Saboos Isapgol with Syrup Cremaffin in patients with uncomplicated Da’imi-Qabz (Chronic Constipation)
Government Tibbi College and Hospital1 site in 1 country60 target enrollmentStarted: June 10, 2024Last updated:
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Government Tibbi College and Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Stool frequency
Overview
Brief Summary
Patients with uncomplicated chronic constipation are enrolled according to inclusion and exclusion criteria, and diagnosis is made by history taking, clinical examination and lab investigation , then, after I give it to a Unani drug named Saboos Isapgol to evaluate the efficacy and safety of the drugs.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 20.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients having the complaints of: 1.Abdominal pain or discomfort 2.Reduced bowel movements (less than 3/week) or infrequent stools 3.Sense of incomplete evacuation 4.Nausea or flatulence 5.Pain at defecation 6.Straining at defecation 7.Patient willing to sign the written informed consent to participate in this trial.
Exclusion Criteria
- •1.Below 20 years and above 60 years of patient.
- •2.Pregnant and lactating women.
- •3.Patients taking other drugs such as atropine and opium group.
- •4.Patients taking any antacid medicine which has aluminium and calcium.
- •5.Associated Complications like Diabetes mellitus, Hypertension, Hyperthyroidism, anal fistula, anal fissure, haemorrhoids, hernia, ano-rectal abscess, etc.
- •6.Mentally retarded person and prisoners.
- •7.Patients with chronic debilitating diseases, or neurologic abnormalities.
- •8.Non ambulatory / Bed ridden patients.
- •9.One who had previous surgery of the colon.
- •10.Patient having diagnosed intestinal structural abnormality.
Outcomes
Primary Outcomes
Stool frequency
Time Frame: baseline, | 1st Follow up at the end of second week
(Number of stools per week)
Time Frame: baseline, | 1st Follow up at the end of second week
Stool consistency
Time Frame: baseline, | 1st Follow up at the end of second week
(1- hard; 2- firm; 3- loose)
Time Frame: baseline, | 1st Follow up at the end of second week
Secondary Outcomes
- Assessment according to ROME Diagnostic Criteria(2nd Follow up at the end of fourth weeks)
Investigators
Saleha Aftab
Government Tibbi College and Hospital
Study Sites (1)
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