A clinical trial to compare the effects of Unani research drug Qurs Mulaiyin with allopathic drug Dulcolax in patients with difficulty in passage of stool

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)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/01/049032

Enrollment

Registered

2023-01-16

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K590- Constipation

Interventions

Intervention1: Qurs Mulaiyin: 2 Cap of 500 mg orally to be taken with water at bedtime for 7days Control Intervention1: Tab Dulcolax: 1 Tab of 10 mg orally to be taken with water at bedtime for 7days

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Improvement in sign and symptoms of Daimi Qabz (Chronic constipation)Timepoint: 1 week	—

Secondary

Measure	Time frame
Hematological and biochemical assessment for safety assessmentTimepoint: 1 week	—

Countries

India

Contacts

Public ContactDr Pradeep Kumar

Central Council for Research in Unani Medicine (CCRUM)

ccrum507@rediffmail.com9213511298

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026