| CTRI Number |
CTRI/2024/10/075874 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
25/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Clinical Study to Examine How HPPE-092402 Can Improve Gut Health in Adults with mild to moderate gastrointestinal symptoms |
|
Scientific Title of Study
|
A Randomized Double-Blind Placebo Controlled Three Arm Study to Evaluate the Role Of HPPE-092402 In Ameliorating Gut Health in Adults with Mild to Moderate Gastrointestinal Symptoms. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HWC/MSCD/PP/032/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajendra Narayana Sharma |
| Designation |
Principal Investigator |
| Affiliation |
Roshni Speciality Clinic |
| Address |
Roshni Speciality Clinic, 23/19, 4th main Rd, Tavarekere Main Rd, Chikka Adugodi, Brindavan Nagar, S.G. Palya, Bengaluru, Karnataka 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
9740199006 |
| Fax |
|
| Email |
dr.r.n.sharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Kumawat |
| Designation |
Head Of Medical Services and Clinical Development |
| Affiliation |
Himalaya Wellness Company |
| Address |
Room No 301, 3rd floor Medical Services and Clinical Development R&D, Makali Tumkur Road, Bangalore-562162
Bangalore
KARNATAKA
562162
India |
| Phone |
8067549904 |
| Fax |
|
| Email |
rajesh.kumawat@himalayawellness.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Soorya Narayan H |
| Designation |
Manager-Clinical Operations |
| Affiliation |
Himalaya Wellness Company |
| Address |
Room No 301, 3rd floor Medical Services and Clinical Development R&D, Makali Tumkur Road, Bangalore-562162
Bangalore
KARNATAKA
562162
India |
| Phone |
8067549919 |
| Fax |
|
| Email |
dr.sooryanarayan.h@himalayawellness.com |
|
|
Source of Monetary or Material Support
|
| Himalaya Wellness Company
Room No 301, 3rd floor Medical Services and Clinical Development R&D, Makali Tumkur Road, Bangalore-562162 |
|
|
Primary Sponsor
|
| Name |
Himalaya Wellness Company |
| Address |
Room No 301, 3rd floor Medical Services and Clinical Development R&D, Makali Tumkur Road, Bangalore-562162 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajendra Narayana Sharma |
Roshni Speciality Clinic |
Roshni Speciality Clinic, 23/19, 4th main Rd, Tavarekere Main Rd, Chikka Adugodi, Brindavan Nagar, S.G. Palya, Bengaluru, Karnataka 560029
Bangalore
KARNATAKA |
9740199006
dr.r.n.sharma@gmail.com |
| Dr Sridhar Sreenivasan Gandhi G |
Sankalpa Multispeciality Hospital |
#47/2, Opp. Vishal Mart, Near BK Circle, Kottunur Dinne, JP Nagar, 8th Phase, Bangalore-560076.
Bangalore
KARNATAKA |
9535234132
Lgsridhar@gmail.com |
| Dr Narendra Reddy M R |
Vita Plus Clinic |
#46, Nayak Layout, Byrappa Circle, Jamboo Savari Dinne, J.P. Nagar 8TH Phase, Bangalore-560076
Bangalore
KARNATAKA |
8073758207
mr.narendrareddy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pranav Diabetes Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
HPBC-092403 |
Ingredients
Lactobacillus,
Bacillus coagulants,
Bacillus Clausi,
Microcrystalline Cellulose,
Caramel,
E veg size "00" capsule
1.Dose: 750 mg
2.Frequency: 1 capsule once daily
3.Route of Administration: Orally
4.Duration: 28 days
|
| Intervention |
HPPE-092402 |
Gut microbes can metabolize herbal compounds and thereby increase their bioavailability and bioactivity, in addition to reducing their toxicity.
Ingredients
Flax seed, Ginger soft extract, Inulin, Microcrystalline cellulose, Lactobacillus plantarum, Bacillus Coagulants, Lactose, Protease, E veg size "00" Capsule
1.Dose: 660 mg
2.Frequency: 1 capsule once daily
3.Route of Administration: Orally
4.Duration:28 days
|
| Comparator Agent |
Placebo |
Ingredient
Microcrystalline cellulose,
Caramel, E veg size "00" capsule
1.Dose: 750 mg
2.Frequency: 1 capsule once daily
3.Route of Administration: Orally
4.Duration: 28 days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and Female subjects between 18 to 45 years.
2. Subjects having mild to moderate Gastrointestinal symptoms like abdominal discomfort, bloating, gas, flatulence, abdominal fullness with GSRS score between 15 to 60.
3. Subjects who have not participated in any other similar clinical study within the last 3 months of screening.
4. Subjects willing to sign informed consent and follow the study procedure.
5.Women of child-bearing potential using reliable method of contraception and willing to adopt the reliable and validated contraceptive methods throughout the study period to avoid pregnancy.
6. Male subjects willing to use adequate/ validated contraception and refrain from donating sperm from entering to the study until 90 days after the follow-up visit.
|
|
| ExclusionCriteria |
| Details |
1.Subjects with known clinically significant cardiovascular, respiratory, cerebrovascular, hepatic, renal, congenital, immunological or any other disorder that can interfere with the study conduct and outcome in the opinion of the Investigator.
2.Subject has chronic health conditions that would prevent him or her from fulfilling the study requirements as judged by the investigator based on medical history and routine laboratory test results.
3.Subjects diagnosed with clinically significant GI disorders (Celiac, peptic ulcer, ulcerative colitis, Crohn disease, cancer).
4.Use of pre-and probiotics within 30 days prior to screening.
5.Subjects with known history or present condition of allergic response to the study drug or any ingredients in the investigational product.
6.Pregnant and lactating women (as assessed by UPT u history of amenorrhea).
7.Known alcohol or any other substance abuse.
8.Any other reason (physical, psychological or social) that can interfere with the subject’s compliance to the study in the opinion of the Investigator.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Safety and Efficacy Assessment of Gastrointestinal tolerability through GSRS (Gastrointestinal Symptoms Rating Scale).
|
Day 1 & Day 7, Day 14, Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Safety evaluation through Incidence of adverse events during the study period.
2.Proportion of subjects withdrawing from study because of adverse
events (tolerability).
|
Day 1 & Day 7, Day 14, Day 28 |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
05/11/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Gut bacteria constitute a vital element of the microbiota ecosystem within the human gastrointestinal tract, which is inhabited by approximately 1014 microbes—tenfold the number of human cells (Thursby E, 2017). These gut bacteria are crucial for maintaining human health, as they provide essential nutrients, synthesize vitamin K, assist in the breakdown of cellulose, and support angiogenesis and the functioning of enteric nerves. (Zhang YJ, 2015) Nevertheless, alterations in their composition can occur, leading to potential harm, particularly when the gut ecosystem experiences disruptions due to factors such as antibiotic use, illness, stress, aging, poor dietary choices, and lifestyle habits. Dysbiosis within the gut bacterial communities has been linked to various chronic conditions, including inflammatory bowel disease, obesity, cancer, and autism. |