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CTRI Number  CTRI/2021/07/034540 [Registered on: 02/07/2021] Trial Registered Prospectively
Last Modified On: 04/10/2021
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Phase IV Post- Marketing Surveillance Study to Measure the Efficacy and Safety of Product PETSAFFA in Subjects Suffering from Constipation  
Scientific Title of Study   A Single Centric, Open Label, Non-Randomized Phase IV Post- Marketing Surveillance Study to Measure the Efficacy and Safety of Product PETSAFFA in Subjects Suffering from Constipation  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abdul Mateen Athar 
Designation  General Physician 
Affiliation  Medlife Clinic 
Address  #81, 5th Main, Minhajnagar, Bangalore-560070

Bangalore
KARNATAKA
560070
India 
Phone  9449767229  
Fax    
Email  mateenathar@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vijay Kimtata 
Designation  Scientific Medical Reviewer 
Affiliation  Divisa Herbal Care 
Address  SCO 135-136, 2nd Floor, Sector 9 C, Above CM Automobiles, Near CITCO Petrol Pump, Madhya Marg, Chandigarh-160009, India

Chandigarh
CHANDIGARH
160009
India 
Phone  9816333352  
Fax    
Email  vijaykimtata.vk@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mr Hasan Ali Ahmed 
Designation  Director 
Affiliation  Xplora Clinical Research Services Pvt. Ltd 
Address  #252, 13th Cross, Wilson Garden, Bangalore-560027

Bangalore
KARNATAKA
560027
India 
Phone  9886012598  
Fax    
Email  hasan@xplorahealth.com  
 
Source of Monetary or Material Support  
Divisa Herbal Care SCO 135-136, 2nd Floor, Sector 9 C, Above CM Automobiles, Near CITCO Petrol Pump, Madhya Marg, Chandigarh-160009, India 
 
Primary Sponsor  
Name  Divisa Herbal Care 
Address  SCO 135-136, 2nd Floor, Sector 9 C, Above CM Automobiles, Near CITCO Petrol Pump, Madhya Marg, Chandigarh-160009, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Abdul Mateen Athar  Medlife Clinic  #81,5th Main, Minhajnagar, Bangalore-560070
Bangalore
KARNATAKA 
9449767229

mateenathar@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: Constipation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Petsaffa  Oral administration of 1 teaspoon of PetSaffa granules with Luke warm water at night before bed  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Age Between 18 and 80
2. Subjects suffering from Constipation
3. Subjects willing to sign ICF with mention health issues
 
 
ExclusionCriteria 
Details  Pregnant, Breastfeeding subjects undergone any surgery and else take taken part in any clinical Trial
2. Not willing to Sign the ICF or give the consent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To determine the percentage of subjects with significant symptomatic reduction of constipation.   Day 1 to Day 21 
 
Secondary Outcome  
Outcome  TimePoints 
1.To assess the safety of IP Petsaffa Granules
2.To assess the percentage of subjects with significant symptomatic reduction of gas and acidity post intervention assessed through Investigator Assessment Scale and Subject Assessment Questionnaires
3.To assess the incidence of AE reported or observed during study period

 
Day 1 to day 21 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   15/07/2021 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  
The Study has been designed to measure the efficacy and safety of product PETSAFFA in subjects suffering from constipation. The Study is single centric, open label, Non-randomized, Phase IV Post marketing surveillance study on 120 subjects. There are four visits in the study with one telephonic follow-up. On screening visit i.e., day 0, the subjects will be screened based on inclusion and exclusion criteria. An informed consent form will be given to all subjects at the screening visit containing all study information in it. After obtaining the consent form, blood will be drawn for laboratory investigations (CBC, Serum creatinine and SGPT). Eligible subjects will be enrolled in the study after the baseline visit (i.e., visit 2). The study Investigator will explain the subject about all study-related processes and the telephonic follow-up Day 14 (Visit 3) and final visit Day 21 (Visit 4). All eligible subjects will then be provided with Test Product – PETSAFFA by Investigator/study co-ordinator on day 1. In the presence of Investigator, the instructions will be given to use the test product at home from Day 1 to Day 21 i.e., Oral administration of 1 teaspoon of PETSAFFA granules with lukewarm water at night before bed. Investigator assessment shall be performed on baseline Day 0 and final visit- Day 21. A self- assessment questionnaire shall be given to all eligible subjects on Baseline and final visit. Blood investigations shall be performed on baseline and final visit.

  

 
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