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CTRI Number  CTRI/2022/01/039843 [Registered on: 31/01/2022] Trial Registered Prospectively
Last Modified On: 28/08/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical study to Evaluate the Efficacy of Gingever in Subjects with Occasional Constipation. 
Scientific Title of Study   A Prospective, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy of Gingever in Subjects with Occasional 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 M E Mohan  
Designation  Principal Investigator  
Affiliation  BGS Global Institute of Medical Sciences  
Address  Department of General Medicine BGS Global Institute of Medical Sciences #67, BGS health and Education city, Uttarahalli road, Kengeri

Bangalore
KARNATAKA
560060
India 
Phone  9482164779  
Fax    
Email  drmohanbgsresearch@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jestin V Thomas 
Designation  Director 
Affiliation  Leads Clinical Research and Bio Services Pvt. Ltd  
Address  Department of Clinical Research, #9, 1st floor, Mythri Legacy, Chelekere main road, Kalyan nagar

Bangalore
KARNATAKA
560043
India 
Phone  9845125293  
Fax    
Email  jestin.leadsclinbio@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jestin V Thomas 
Designation  Director 
Affiliation  Leads Clinical Research and Bio Services Pvt. Ltd  
Address  Department of Clinical Research, #9, 1st floor, Mythri Legacy, Chelekere main road, Kalyan nagar


KARNATAKA
560043
India 
Phone  9845125293  
Fax    
Email  jestin.leadsclinbio@gmail.com  
 
Source of Monetary or Material Support  
OmniActive Health Technologies Ltd.T-8b, 5th Floor, Phoenix House, A wing, Phoenix Mills Compound, 462 Senapati Bapat Marg, Lower Parel, Mumbai – 400013, India 
 
Primary Sponsor  
Name  OmniActive Health Technologies Ltd 
Address  .T-8b, 5th Floor, Phoenix House, A wing, Phoenix Mills Compound, 462 Senapati Bapat Marg, Lower Parel, Mumbai – 400013, India 
Type of Sponsor  Other [Manufacturer of natural plant based food ingredients and Nutraceutical ingredients] 
 
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 M E Mohan   BGS Global Institute of Medical sciences   Department of General Medicine, Room No:1,BGS Global Institute of Medical Sciences #67, BGS health and Education city, Uttarahalli road, Kengeri
Bangalore
KARNATAKA 		 9482164779

drmohanbgsresearch@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BGS Global Institute of Medical Scineces Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  With Occasional Constipation 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Gingiver   Oral administration of single dose of Gingever capsules everyday for 56 days  
Comparator Agent  Placebo  Oral administration of single dose of Placebo capsules everyday for 56 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. BMI of 18.5 kg/m2 to 29.9 kg/m2
2. subjects who have less than 3 bowel movements per week for at least 2 weeks
3. Subjects who agree to maintain their usual level of activity throughout the trial period
4. Subjects who agree to maintain their usual dietary habits and level of exercise i.e. maintain their usual life-style throughout the trial period.
5. Subjects who agree to stay weight stable during the study period.
6. Female subjects of child bearing potential practicing an acceptable method of birth control
7. Subjects willing to provide written consent.
8. 9. Subjects shall be willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.

 
 
ExclusionCriteria 
Details  1. Having hypersensitivity or history of allergy to the study product.
2.Suffering from a metabolic disorder
3. Subjects diagnosed with functional constipation as per Rome III criteria
4. Major gastrointestinal complication
5. Subjects suffering from lactose intolerance
6. Prior abdominal surgery
7. Current pharmacological treatment related to constipation
8. Laxative/suppository use
9. Daily consumption of probiotics, prebiotics, symbiotic, fibres, fermented milk, and/or yogurt containing probiotics within 1 month prior to screening.
10. Use of any drug or dietary supplement during at least 7 consecutive days known to cause constipation
11. Clinically significant underlying systemic illness that may preclude the participants ability to complete the trial or that may confound the study outcomes
12. Systemic steroid use within 1 month before screening.
13. Eating disorder
14. Having a lifestyle deemed incompatible with the study according to the investigator
15. Self-declare history of alcohol abuse
16. Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
17. Subjects with positive Urine Pregnancy Test at Screening/Randomization Visit.
18. Other causes of secondary constipation
19. Subjects who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry.
20. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.


 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean change from baseline in abdominal, rectal and stool related symptoms and change in fecal microbiota composition   Day 0, Day 3, Day 14, Day 28, Day 56 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change from baseline in stool frequency as assessed by number of bowel movements  Day 0, Day 3, Day 14, Day 28, Day 56 
Mean change from baseline in stool consistency   Day 0, Day 3, Day 14, Day 28, Day 56 
Mean change from baseline in gut immunity markers  Day 0, Day 56 
Mean change from baseline in inflammatory markers  Day 0, Day 56 
Mean change from baseline in fecal Short Chain Fatty Acids   Day 0, Day 56 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/01/2022 
Date of Study Completion (India) 27/04/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   "None Yet" 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is a randomized, double-blind, parallel, placebo-controlled, clinical interventional study. Adult healthy males and/or females aged between 18 and 65 years who report with less than  3 bowel movements per week for at least 2 weeks. and meet all inclusion and no exclusion criteria will be enrolled in the study after signing a written informed consent. If a subject is eligible for study participation, at Randomization Visit (Visit 2), subjects will be randomly (Double-blind) assigned in 1:1 ratio to one of the two (2) treatment groups i.e. Test Product or Placebo. Clinical assessments and Quality of life will be assessed by questionnaire based assessments. stool samples and blood samples will be collected for the assessment of efficacy parameters. A Subject Diary will be provided to the subjects to record the study IP administration, frequency of bowel movements, side effects and concomitant medication details including rescue medications, any sick leaves during the study duration. All subjects will be instructed to complete the Subject Diary after each study IP administration. Any additional and missed administrations should also be noted in the Subject Diary. Subject Diary will be used to evaluate study IP administration compliance. study is planned to be conducted in 5 visits over a period of 56 days.

  
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