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

Phase 2

Not yet recruiting

• Conditions: Constipation,

• Registration Number: CTRI/2023/01/049032
• Lead Sponsor: Central Council for Research in Unani Medicine (CCRUM), New Delhi

Brief Summary

This study is designed as a single blind randomized parallel group trial in patients with Daimi Qabz(Chronic Constipation).  Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients enrolled in the study will receive the medicine Qurs Mulaiyin or Tab Dulcolax as allocated by randomization method. The total duration of treatment will be one week and the follow-up for all clinical parameters will be conducted at 3rd& 7th day. The laboratory tests will be conducted at baseline and end of the treatment.

Composition of *Qurs Mulaiyin*

| | | | |

| --- | --- | --- | --- |

|**S. No.**

**Ingredients**

**Botanical / English Name**

**Quantity**

|

Zanjabeel

*Zingiberofficinale*Rosc.

6 gm

|

Sana

*Cassia augustifolia*Vahl

6 gm

|

Gul-e-Surkh

*Rosa damascena*Mill

3 gm

|

Bekh-e-Jalapa

*Ipomoea purga*Hayne

6 gm

|

Namak Lahori

 1.5 gm

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-17
• Last Update Posted: 2023-12-10

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Participants of either sex in the age group 18 to 65 years.
• 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

• Patients on chronic laxative medication (>60 days) and/or who were on medications known to cause constipation (like opioid analgesics, antidepressants, anticonvulsants) were excluded.
• Known case of a megacolon/megarectum.
• Known cases of HIV/AIDS, cancer, etc.
• 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.
• Known hypersensitivity to study drug or any of its ingredients 6.
• Pregnant and Lactating females 7.
• Any systemic disorder requiring prolonged treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in sign and symptoms of Daimi Qabz (Chronic constipation)	1 week

Secondary Outcome Measures

Name	Time	Method
Hematological and biochemical assessment for safety assessment	1 week

Trial Locations

Locations (1)

Regional Research Institute of Unani Medicine (RRIUM), Chennai; 🇮🇳 Chennai, TAMIL NADU, India

Regional Research Institute of Unani Medicine (RRIUM), Chennai

🇮🇳Chennai, TAMIL NADU, India

Dr Farooqui Shazia Parveen Barkat Ali

Principal investigator

8147438868

shaziafarooquinium@gmail.com