| CTRI Number |
CTRI/2024/11/076250 [Registered on: 04/11/2024] Trial Registered Prospectively |
| Last Modified On: |
07/11/2024 |
| 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 Study to assess the Effect of the Natural Orange Extract in Individuals with Gastrointestinal Discomfort |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Two-Arm, Placebo-Controlled Clinical Study to assess the Effect of the Natural Orange Extract in Individuals with Gastrointestinal Discomfort |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HT/240501/CARD/GID Ver No: 1.0 Date: 05th September, 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSanjay Vaze |
| Designation |
Sr.Manager-Clinical Development |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road
Andheri West Mumbai Mumbai (Suburban) MAHARASHTRA 400053
Mumbai MAHARASHTRA 400053 India
Mumbai
MAHARASHTRA
400053
Mumbai (Suburban)
MAHARASHTRA
400053
India |
| Phone |
8655670964 |
| Fax |
|
| Email |
sanjay.v@vediclifesciences.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSanjay Vaze |
| Designation |
Sr.Manager-Clinical Development |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road
Andheri West Mumbai Mumbai (Suburban) MAHARASHTRA 400053
Mumbai MAHARASHTRA 400053 India
Mumbai
MAHARASHTRA
400053
Mumbai (Suburban)
MAHARASHTRA
400053
India |
| Phone |
8655670964 |
| Fax |
|
| Email |
sanjay.v@vediclifesciences.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubhangi Mote |
| Designation |
Project Lead. |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road
Andheri West Mumbai Mumbai (Suburban) MAHARASHTRA 400053
Mumbai MAHARASHTRA 400053 India
Mumbai
MAHARASHTRA
400053
Mumbai (Suburban)
MAHARASHTRA
400053
India |
| Phone |
8655448527 |
| Fax |
|
| Email |
shubhangi.m@vediclifesciences.com |
|
|
Source of Monetary or Material Support
|
| Vedic Lifesciences Pvt. Ltd. 118-B, Morya House, off New Link Road, Andheri West Mumbai
–400053, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Vedic Lifesciences Pvt. Ltd |
| Address |
Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road
Andheri West Mumbai Mumbai (Suburban) MAHARASHTRA 400053
India |
| Type of Sponsor |
Contract research organization |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dhamne Akshay Anant |
Pawna Hospital |
Pawna Hospital, Department Medicne,Ground Floor OPD N0-01, Urse parandwadi Road, Somatne Phata, Maval, Gastroenterologist Department
Pune 410506
Pune
MAHARASHTRA |
9168469303
drakshay.pawana@gmail.com |
| Dr Kushal Bangar |
Shivam Hospital |
Shivam Hospital;Consulting 2, Basement Floor Plot no. 57, C.R.W. CHS, Near M.I.D.C, water tank, Kalyan Road, Dombivli (East), 421201
Thane
MAHARASHTRA |
9545664884
dr.kushal.bangar83@gmail.com |
| Dr Bharatkumar Dholu |
Shree Samarth Hospital |
OPD NO.2 ,227 Gastro Department Shree Samarth Hospital, Omkar Apartment, Karande Chowk, Rasta Peth, Pune
Pune
MAHARASHTRA |
8805387387
drbkddholu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Altezza Institutional Ethics Committee |
Approved |
| Skinovate Independent Ethics committee |
Not Applicable |
| Skinovate Independent Ethics committee |
Not Applicable |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K90-K95||Other diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IP |
One capsule of 500 mg to be taken with breakfast orally once a day for 90 day |
| Comparator Agent |
Placebo |
One capsule of 500 mg to be taken with breakfast orally once a day for 90 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals willing to give written informed consent form voluntarily to participate in the study
2. Healthy males and females of age between 18-65 years.
3. Individuals with a Body Mass Index (BMI) between 18.5-29.9 kg/m2 (both values included).
4. Individuals with a history of GI discomfort, associated with changes in the frequency and form of stools for the last 3 months, with symptom onset at least 6 months.
5. Individuals with complaints of loose or watery stools, occurring in more than 25% of stools for the last 3 months.
6. Individuals with consistent and stable body weight in the last 3 months prior to screening (less than 5% self-reported change).
7. Individuals with a baseline score of less than or equal to 55 for the digestive domain score of the Gastrointestinal Quality of Life Index (GIQLI).
8. Individuals with Fasting Blood Glucose (FBG) less than equal to 125 mg/dl.
9. Individuals with systolic blood pressure (SBP) less than 140 and/or diastolic blood pressure (DBP) less than 90 mm Hg.
10. Individuals willing to avoid consumption of citrus-based products during the entire study duration.
11. Individuals willing to follow all the study procedures and follow-up visits as per protocol. |
|
| ExclusionCriteria |
| Details |
1. Individuals diagnosed with diabetes mellitus and are on active medication.
2. Individuals diagnosed with hypertension and are on active medication.
3. Individuals with thyroid dysfunction as assessed by Thyroid Stimulating Hormone (TSH) less than or equal to 0.4 or more than or equal to 5.0 mIU/L will be excluded.
4. Individuals with a history and/or presence of acute or chronic significant GI disease or digestion/absorption disorders (e.g., Irritable bowel syndrome, inflammatory bowel disease, infectious diarrhea, coeliac disease, Clostridium difficile colitis, malabsorption, pancreatitis, disorders in digestive tract motility, gluten enteropathy, etc).
5. Individuals with a history of autoimmune disorders.
6. Individuals with major gastric, hepatic, biliary, pancreatic, or intestinal surgery within the last 6 months prior to screening or planned during the study (appendectomy, haemorrhoidectomy, or polypectomy allowed as long as occurred more than 3 months prior to screening; uncomplicated laparoscopic or open cholecystectomy is allowed if no history of post-operative biliary tract pain and surgery occurred more than 3 months prior to screening).
7. Any other relevant serious organ or systemic diseases (e.g., cardiovascular, respiratory, liver, renal, neurological disease, etc).
8. Individuals with a history of malignancy within last five years.
9. Use of immunosuppressive drugs within 3 months prior to the screening.
10. Use of oral corticosteroids within 1 month prior to the screening.
11. Excessive alcohol drinking (For men, consuming five or more drinks on any day or 15 or more per week; for women, consuming four or more on any day or 8 or more drinks per week). One unit of alcohol is equal to 45 ml of hard liquor, 150 ml of wine or a pint of beer.
12. Individuals with a history of/known allergies to citrus fruits or citrus-based products.
13. Individuals taking any antibiotics in the past 4 weeks and during the study.
14. Individuals who are on regular intake of laxatives in the past 1 month prior to the screening.
15. Individuals taking any dietary supplements, and medication for any gastrointestinal or metabolic disease (peptic ulcer, IBS, type-II diabetes, atherosclerosis, etc.)
16. Individuals taking any hormones for any gastrointestinal or metabolic disease within 3 months prior to screening.
17. Individuals taking any probiotics, prebiotics, post-biotics or synbiotics within 3 months prior to the screening.
18. History of smoking or currently smoking.
19. Individuals with gluten and/or lactose intolerance.
20. Females who are pregnant/lactating or planning to be pregnant.
21. Individuals who have participated in another clinical study(ies) with an IP within 90 days before screening, or who plan to participate in another study during the study period.
22. Any other conditions, which in the opinion of the investigator may jeopardize the study. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effect of the IP on gastrointestinal digestion symptoms as assessed by the change in digestive domain scores of the Gastrointestinal Quality of Life Index (GIQLI) compared to baseline and placebo.
|
Day 0, Day 45, Day 90.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the effect of IP on the following compared to baseline and placebo
1.Gastrointestinal quality of Life as assessed by GIQLI
2.Stool consistency as assessed by the Bristol Stool Form Scale (BSFS)
3.Percentage responders as assessed by the change in the frequency of BSFS stool types 6 & 7 [Percentage responders are defined as responders having more than 80% of BSFS stool types 3,4,5 at the end of the study as compared to baseline]
4.Gastrointestinal symptoms as assessed by the Gastrointestinal Symptoms Rating scale (GSRS) |
Day 0, Day 45, Day 90 |
To assess the effect of IP on the following compared to baseline and placebo
1.Intestinal permeability as assessed by serum levels of Lipopolysaccharide binding protein (LBP)
2.Inflammation as assessed by Interleukin-6 (IL-6), Interleukin-10 (IL-10) and Tumor Necrosis Factor-alpha (TNF-α).
3. Intestinal inflammation as assessed by fecal calprotectin.
4. Microbial metabolic activity as assessed by fecal short-chain fatty acids (SCFA) [Acetate, Butyrate and Propionate]
5.The gut microbiome as assessed by Next Generation Sequencing (NGS) |
Day 0 & Day 90 |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/11/2024 |
| 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="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The study is a randomized, double-blind, two-arm, placebo-controlled clinical study. NLT 78 individuals will be screened, and considering a screening failure rate of 20%, approximately 64 will be randomized in a ratio of 1:1 to receive either active or placebo and will be assigned a unique randomization code. After accounting for a dropout/withdrawal rate of 20%, there will be NLT 50 individuals who will complete the study |