| CTRI Number |
CTRI/2023/01/049032 [Registered on: 16/01/2023] Trial Registered Prospectively |
| Last Modified On: |
12/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
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 |
|
Scientific Title of Study
|
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) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Q/AU/HQ/CLNVAL/CCRUM/19-20, version 02, 18-11-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Asim Ali Khan |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 502, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
unanimedicine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 507, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
9213511298 |
| Fax |
|
| Email |
ccrum507@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer (Pathology) S-IV |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 516, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
8800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support : 1 Regional Research Institute of Unani Medicine (RRIUM), Aligarh Monetary Support: Central Council for Research in Unani Medicine (CCRUM), New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine (CCRUM), New Delhi |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Farooqui Shazia Parveen Barkat Ali |
Regional Research Institute of Unani Medicine (RRIUM), Chennai |
Research OPD Room Daimi Qabz(Chronic Constipation), No. 1, West Mada Church Road, Royapuram, Chennai-600013
Chennai
TAMIL NADU |
8147438868
shaziafarooquinium@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Regional Research Institute of Unani Medicine, Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K590||Constipation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Qurs Mulaiyin |
2 Cap of 500 mg orally to be taken with water at bedtime for 7days |
| Comparator Agent |
Tab Dulcolax |
1 Tab of 10 mg orally to be taken with water at bedtime for 7days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in sign and symptoms of Daimi Qabz (Chronic constipation) |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hematological and biochemical assessment for safety assessment |
1 week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
17/01/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 | ZingiberofficinaleRosc. | 6 gm | -
| Sana | Cassia augustifoliaVahl | 6 gm | -
| Gul-e-Surkh | Rosa damascenaMill | 3 gm | -
| Bekh-e-Jalapa | Ipomoea purgaHayne | 6 gm | -
| Namak Lahori | | 1.5 gm | |