| CTRI Number |
CTRI/2019/11/022190 [Registered on: 27/11/2019] Trial Registered Prospectively |
| Last Modified On: |
18/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
Boswellia serrata extract 200 mg capsules in subject with Irritable Bowel Syndrome. |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled, parallel study, to evaluate the safety and efficacy of Boswellia serrata extract 200 mg capsules of Inventia Healthcare Limited in subjects with Irritable Bowel Syndrome (IBS)
|
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandeep Singh |
| Designation |
Director Operations |
| Affiliation |
CBCC Global Research LLP |
| Address |
Clinical Operations Department, Room Number 2, East Wing, Second Floor Skoda House Opposite L J Campus S G Highway Sarkhej Ahmedabad – 382210, India
Ahmadabad
GUJARAT
382210
India |
| Phone |
|
| Fax |
9726434204 |
| Email |
sandeep.singh@cbccusa.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Singh |
| Designation |
Director Operations |
| Affiliation |
CBCC Global Research LLP |
| Address |
Clinical Operations Department, Room Number 2, East Wing, Second Floor Skoda House Opposite L J Campus S G Highway Sarkhej Ahmedabad – 382210, India
Ahmadabad
GUJARAT
382210
India |
| Phone |
|
| Fax |
9726434204 |
| Email |
sandeep.singh@cbccusa.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Singh |
| Designation |
Director Operations |
| Affiliation |
CBCC Global Research LLP |
| Address |
Clinical Operations Department, Room Number 2, East Wing, Second Floor Skoda House Opposite L J Campus S G Highway Sarkhej Ahmedabad – 382210, India
Ahmadabad
GUJARAT
382210
India |
| Phone |
|
| Fax |
9726434204 |
| Email |
sandeep.singh@cbccusa.com |
|
|
Source of Monetary or Material Support
|
| Inventia Healthcare Limited
Unit 703, 704, 7th Floor, Hubtown Solaris,
N.S. Phadke Marg, Andheri (East),
Mumbai – 400069 |
|
|
Primary Sponsor
|
| Name |
Inventia Healthcare Limited |
| Address |
Inventia Healthcare Limited
Unit 703, 704, 7th Floor, Hubtown Solaris,
N.S. Phadke Marg, Andheri (East),
Mumbai – 400069
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jignesh Shah |
Het Medical Hospital |
405 (4th Floor), Radhekishan Arista, Opp. Hirabhai Tower, Maninagar,
Ahmedabad - 380028, Gujarat, India
Ahmadabad
GUJARAT |
9904333669
drjignesh81@gmail.com |
| Dr Tapan Shah |
Sangini Hospital |
1st Floor, Santorini Square, Opp. Star Bazar Lane, B/H Abhishree Complex, Satellite, Ahmedabad-380015, Gujarat, India
Ahmadabad
GUJARAT |
9825739241
drtapanshah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Sangini Hospital Ethics Committee |
Approved |
| Sangini Hospital 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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Boswellia Serrata Extract Capsules 200mg |
Boswellia Serrata
Dose:200mg
Frequency:Once Daily
Route of Administration:Oral
Duration of Therapy:84 Days |
| Comparator Agent |
Placebo |
NIL |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects must be able to provide voluntary written informed consent and to follow protocol requirements
Male and female subjects aged between 18 to 65 years both inclusive
Subjects diagnosed with IBS as per Rome 4 criteria at the time of screening. Rome 4 Diagnostic Criteria includes
Recurrent abdominal pain on average at least 1 day per week in the last 3 months associated with two or more of the following
Related to defecation
Associated with a change in frequency of stool
Associated with a change in form appearance of stool
Note Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
Willingness to complete subject diaries and respond to study questionnaires
Women of childbearing potential (defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the investigational product) practicing two acceptable methods of contraception
Acceptable methods of contraception are
Oral or other For Example injection patch or implant hormonal contraception which has been used continuously for at least one month prior to the first dose of study medication
Intrauterine device IUD or intrauterine system IUD or IUS
Double barrier method of contraception condom and occlusive cap or condom and spermicidal agent
Male sterilization at least 6 months prior to the screening should be the sole male partner for that subject
Female sterilization surgical bilateral oophorectomy or tubal ligation at least 6 weeks prior to study participation
Total abstinence partial abstinence is not acceptable
|
|
| ExclusionCriteria |
| Details |
The subjects must not meet any of the following exclusion criteria:
1. Hypersensitivity to any of the components of Boswellia serrata extract or any of the ingredients of the formulations.
2. Gastrointestinal bacterial infection or parasite infestation
3. History of major gastrointestinal surgery
4. History of intolerance/ allergy to any food items
5. Any intervention for IBS in the period of last 4 weeks
6. History or presence of carcinoma colon or ulcerative colitis
7. Pregnant or lactating women
8. History or presence of any uncontrolled debilitating systemic disease (including but not limited to cardiovascular disease, hypertension, diabetes mellitus type I and II, chronic liver disease including cirrhosis, chronic kidney disease etc.)
9. Subjects with major surgical procedure (including periodontal) within 28 days prior to the first dose of Investigational Product.
10. Subjects having the following laboratory results at screening:
a. Hemoglobin (Hb) less than 9 g/dL
b. AST and ALT > 3.0 x ULN
c. Alkaline phosphatase > 3.0 x ULN
d. Serum Creatinine level > 1.25 x ULN
11. Subjects on anticoagulant and/or antiplatelet medications such as aspirin, clopidogrel or warfarin.
12. Subjects with surgical or other non-healing wounds.
13. Subjects with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV)
14. Participation in any clinical study within 30 days prior to receiving the first dose of Investigational Product.
15. Any other medical condition or serious intercurrent illness that, in the opinion of the investigator, may make it undesirable for the subject to participate in the study including but not limited to psychiatric illness/social situations that would limit adherence to study requirements.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Boswellia serrata extract 200 mg capsules in subjects with IBS |
The primary Outcome will be assessed data obtained on 84th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the change in gut microbiota due to Boswellia serrata extract 200 mg capsules.
To monitor the safety and tolerability of Boswellia serrata extract 200 mg capsules
|
The Secondary Outcome will be assessed data obtained on 84th day. |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/12/2019 |
| Date of Study Completion (India) |
16/06/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The Study is a randomized, double-blind, placebo-controlled, parallel study, to evaluate the safety and efficacy of Boswellia serrata extract 200 mg capsules in subject with Irritable Bowel Syndrome Primary Objective: To assess the efficacy of Boswellia serrata extract 200 mg capsules in subjects with IBS Secondary Objective: To evaluate the change in gut microbiota due to Boswellia serrata extract 200 mg capsules. To monitor the safety and tolerability of Boswellia serrata extract 200 mg capsules |