FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/05/068120 [Registered on: 30/05/2024] Trial Registered Prospectively
Last Modified On: 30/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Other 
Public Title of Study   Treatment of uncomplicated chronic constipation with Unani medicine 
Scientific Title of Study   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) 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Saleha Aftab 
Designation  PG Scholar 
Affiliation  Government Tibbi College and Hospital 
Address  Deptt. of Moalajat, Government Tibbi College and Hospital, Arya Road, Kadamkuan, Patna, Bihar

Patna
BIHAR
800003
India 
Phone  8373934454  
Fax    
Email  salehaaftab01@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof. Dr. Shahnawaz Akhtar 
Designation  Professor and HOD 
Affiliation  Government Tibbi College and Hospital 
Address  Department of Amraz e jild wa tazeeniyat (Skin). Government Tibbi College and Hospital, Kadamkuan, Patna, Bihar- 800003

Patna
BIHAR
800003
India 
Phone  9411209323  
Fax    
Email  amudrshahnawaz@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Md Najibur Rahman 
Designation  HOD Incharge 
Affiliation  Government Tibbi College and Hospital 
Address  Department of Moalajat, Government Tibbi College and Hospital, Arya road, Kadamkuan, Patna, Bihar

Patna
BIHAR
800003
India 
Phone  7004484257  
Fax    
Email  dr.md.najibur.rahman@gmail.com  
 
Source of Monetary or Material Support  
Government Tibbi College and Hospital, Patna 
 
Primary Sponsor  
Name  Government Tibbi College and Hospital 
Address  Government Tibbi College and Hospital, Arya road, Kadam kuan, Patna, Bihar-800003 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Saleha Aftab  Government Tibbi College and Hospital  Room no.29, OPD area, Department of Medicine, Govt. Tibbi College and Hospital, Patna-800003
Patna
BIHAR 		 8373934454

salehaaftab01@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Government Tibbi Collge and Hospital, Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K929||Disease of digestive system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Saboos Isapgol  Dose-12gm, Frequency-Single dose at bed time. Route of administration- Orally. Duration- 4 weeks. 
Comparator Agent  Syrup Cremaffin  Dose-15ml Frequency-Single dose at bed time. Route of administration- Orally. Duration- 2 weeks.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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.
11.Patient with phlegmatic temperament.
12.Patient who’s not agree to give consent 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Stool frequency
(Number of stools per week)
Stool consistency
(1- hard; 2- firm; 3- loose) 		 baseline,
1st Follow up at the end of second week 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment according to ROME Diagnostic Criteria  2nd Follow up at the end of fourth weeks 
 
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)   10/06/2024 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.  
Close