CTRI Number	CTRI/2022/08/044941 [Registered on: 25/08/2022] Trial Registered Prospectively
Last Modified On:	26/09/2023
Post Graduate Thesis	No
Type of Trial	Interventional
Type of Study	Drug
Study Design	Randomized, Parallel Group, Active Controlled Trial
Public Title of Study	Clinical trial to evaluate efficacy and safety of Vestige Aloe Vera capsules in patients suffering from irritable bowel syndrome.
Scientific Title of Study	A prospective, multicenter, open label, active controlled, randomized clinical trial to evaluate efficacy and safety of Vestige Aloe Vera capsules in patients suffering from irritable bowel syndrome.
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)	Name  Dr Devesh Kumar  Address  C-120,3rd Floor, Noida Sector -02, Uttar Pradesh - 201301 Gautam Buddha Nagar UTTAR PRADESH 201301 India  Phone  7827758840   Fax     Email  devesh.kumar@innovate-research.com
Details Contact Person Scientific Query Modification(s)	Name  Dr Devesh Kumar  Address  C-120,3rd Floor, Noida Sector -02, Uttar Pradesh - 201301 Gautam Buddha Nagar UTTAR PRADESH 201301 India  Phone  7827758840   Fax     Email  devesh.kumar@innovate-research.com
Details Contact Person Public Query Modification(s)	Name  Dr Devesh Kumar  Address  C-120,3rd Floor, Noida Sector -02, Uttar Pradesh - 201301 Gautam Buddha Nagar UTTAR PRADESH 201301 India  Phone  7827758840   Fax     Email  devesh.kumar@innovate-research.com
Source of Monetary or Material Support	Vestige Marketing Pvt Ltd., A-89, Okhla Industrial Area Phase II New Delhi 110020
Primary Sponsor	Name  Vestige Marketing Pvt Ltd  Address  A-89, Okhla Industrial Area Phase II New Delhi 110020   Type of Sponsor  Pharmaceutical industry-Indian
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr Harsh Mittal  Panchsheel Hospital Pvt. Ltd.  Department of medicine, OPD room basement, Panchsheel Hospital C-3/C-4A 64A Opp. Gokulpuri Police Station, Yamuna Vihar North East DELHI 110053 North   9560506410 harshmittal86@gmail.com
Details of Ethics Committee	No of Ethics Committees= 1   Name of Committee  Approval Status  Institutional Ethics Committee  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Patients  Disease of digestive system, unspecified
Intervention / Comparator Agent Modification(s)	Type  Name  Details  Comparator Agent  standard of care therapy   standard of care therapy in discretion of Investigator  Intervention  Vestige Aloe Vera Capsule   Frequency: - One Capsule to be taken 2 times a day orally before meals. total duration: - 56 days Route of administration: - Oral
Inclusion Criteria Modification(s)	Age From  18.00 Year(s) Age To  65.00 Year(s) Gender  Both  Details  Subject is willing and able to give written informed consent. Male and Female subjects aged 18 and 65 years IBS according to the Rome III criteria The Rome III criteria is based on pain symptoms and considers pain to be the primary symptom of IBS. The Rome III criteria require recurrent abdominal pain or discomfort at least 3 days/month in the last 3 months, which is associated with two or more of the following: • Improvement with defecation • Onset associated with a change in stool frequency • Onset associated with a change in stool form (appearance) Patients who are taking any medication should continue the same dosage during the study. Subject is willing, able, and likely to comply with all study procedures and restrictions.
ExclusionCriteria	Details  1. Any gross Gastrointestinal pathology 2. Suffering from any chronic neuroendocrine or metabolic disorders. 3. Patients who are too sick for consultation 4. Diagnosed cases of unstable mental or psychiatric illness or other systemic disease affecting quality of life 5. Major gastro-intestinal surgery in last 6 month 6. Pregnant and lactating women 7. Any other condition that in the investigator’s judgment might interfere with study objectives
Method of Generating Random Sequence	Computer generated randomization
Method of Concealment	An Open list of random numbers
Blinding/Masking	Open Label
Primary Outcome Modification(s)	Outcome  TimePoints  Bowel function-stool frequency and consistency  Day 0 to Day 56
Secondary Outcome Modification(s)	Outcome  TimePoints  Abdominal symptoms (questionnaire based) The Quality-of-Life Scale (QOLS) Safety and tolerability of the study drug(s) will be assessed by the Clinical AEs occurring during entire duration of study. [ Time Frame: Day 0 to Day 56]   Day 0 to Day 56
Target Sample Size	Total Sample Size="50" Sample Size from India="50"
Phase of Trial	Phase 4
Date of First Enrollment (India) Modification(s)	01/09/2022
Date of First Enrollment (Global)	No Date Specified
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	NIL
Brief Summary Modification(s)	Irritable bowel syndrome (IBS) has confused medical experts and doctors for years. It’s not hard to see why because IBS doesn’t relate to only one but several related and often contradictory conditions. IBS is an increasingly common problem with many symptoms and is hard to treat. Keeping your gut bacteria healthy with Prebiotics could help relieve the suffering. Find out how these special fibers could help you live a normal life again. It seems that food allergies are one of the major triggers of IBS. Clinical research has identified the most common offenders to be grains, especially the gluten in wheat, dairy products, caffeine and citrus fruits.