| 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
|
|
|
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
|
|
|
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. |