| CTRI Number |
CTRI/2024/07/071248 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical study of De-Stress & Happy Gut powder for stress and indigestion in adults. |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled, parallel arm clinical trial of De-Stress and Happy Gut powder in relieving stress and functional dyspepsia symptoms in adults. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/24-25/015 Ver. 1.00 Dated 25-June-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramshyam Agarwal |
| Designation |
Principal Investigator |
| Affiliation |
Lokmanya Medical Research Centre and Hospital |
| Address |
Room no 401 OPD Fourth-floor 314-B Telco Road Chinchwad
Pune
MAHARASHTRA
411033
India |
| Phone |
8087282022 |
| Fax |
- |
| Email |
ramshyam.research@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kriti Soni |
| Designation |
Global Head R and D |
| Affiliation |
Herbolab India Pvt. Ltd. |
| Address |
3rd Floor - A Wing, Marwah Centre, Krishanlal Marwah Marg, Marol, Andheri East.
Mumbai
MAHARASHTRA
400072
India |
| Phone |
9871018383 |
| Fax |
- |
| Email |
kriti.soni@rpsg.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kriti Soni |
| Designation |
Global Head R and D |
| Affiliation |
Herbolab India Pvt. Ltd. |
| Address |
3rd Floor - A Wing, Marwah Centre, Krishanlal Marwah Marg, Marol, Andheri East.
Mumbai
MAHARASHTRA
400072
India |
| Phone |
9871018383 |
| Fax |
- |
| Email |
kriti.soni@rpsg.in |
|
|
Source of Monetary or Material Support
|
| Herbolab India Pvt Ltd Floor - 6th, F-15 ,Plot 78, Commerce Centre, Pandit Madan Mohan Malviya Marg, Tardeo, Mumbai, 400034 |
|
|
Primary Sponsor
|
| Name |
Herbolab India Pvt Ltd |
| Address |
3rd Floor - A Wing, Marwah Centre, Krishanlal Marwah Marg, Marol,
Andheri East MUMBAI, MAHARASHTRA, 400072. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramshyam Agarwal |
Lokmanya Medical Research Centre and Hospital |
room no 401 OPD 4th Floor 314 B Telco Road
Chinchwad
Pune
MAHARASHTRA |
8087282022
-
ramshyam.research@gmail.com |
| Dr Mandar Doiphode |
Sangvi Multispeciality Hospital Pvt. Ltd. |
Sr.No. 71/1/2/189 City Survey No. 2387 Krushna Chowk, Krushna Nagar, New Sangvi
Pune
MAHARASHTRA |
9850077168
-
drmandar.sangvihospital@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Lokmanya Medical Research Centre |
Approved |
| Institutional Ethics Committee Sangvi Multispeciality Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Stress and dyspepsia symptoms |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
De-Stress & Happy Gut powder-I001 |
Take one sachet daily, 30 minutes before breakfast, for 60 days. |
| Intervention |
De-stress & happy gut powder-U001 |
Take one sachet daily, 30 minutes before breakfast, for 60 days. |
| Comparator Agent |
Placebo Powder 001 |
Take one sachet daily, 30 minutes before breakfast, for 60 days. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and female participants aged 21-50 years both inclusive 2.Suffering from self-reported mild to moderate stress on the PSS scale score less than or equal to 26 3.Participants willing to participate in clinical trials and who have read understood and signed the informed consent form 4.No severe anxiety and depression i.e, Generalized anxiety disorder GAD score less than or equal to 10 and Patients’ health questionnaire-9 PHQ-9 score less than or equal to 14 5.Diagnosis of functional dyspepsia/non-ulcer dyspepsia by fulfilling Rome-III criteria 6.Participant should be suffering with at least 4 or more symptoms mentioned below and with a total symptom score of 20 or more based on a 7-point Likert scale (a) Upper abdominal fullness (b) Upper abdominal pain (c) Belching (d) Bloating (e) Early satiety (f) Nausea (g) Vomiting (h) Regurgitation (i) Heartburn (j) Loss of appetite |
|
| ExclusionCriteria |
| Details |
1.Inability to perform any of the assessments required for endpoint analysis
2.Known hypersensitivity to investigational products
3.Participants with a history of substance abuse, drugs, heavy use of alcohol, and/or smoking within last 5 years
4.Advanced chronic illness that would impair follow-up or monitoring
5.Participants who have used dietary supplements, medications, such as oral/IV antibiotics or probiotics, or supplements known to affect hunger, satiety, appetite, or gut microbiome within three months prior to recruitment. Additionally, individuals currently using nutraceuticals, allopathic, or ayurvedic supplements for stress and or gastrointestinal health management;
6.Participants suffering from abdominal obesity that is waist circumference of more than 80 cm in females and of more than 90 cm in male;
7.Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study
8.Participants with current or past diagnoses of peptic ulcer disease, gastroesophageal reflux disorder (GERD), or irritable bowel syndrome (IBS), as well as those who have undergone surgery related to these conditions
9.Have any other neurodegenerative diseases, mental illness or dementia
10.Any other clinical condition in the judgment of investigator finds the study participation unsuitable for the participant. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcomes are as follows-
1.Changes in perceived stress scale (PSS) score, the short-form Nepean Dyspepsia Index (NDI),COPE Questionnaire (a. Positive Subscale b. Denial Subscale) score, Assessing Gut health using a Gastrointestinal Symptom Rating Scale (GSRS) score
2.Time in seconds for relief from pain and heartburn in 5-10 subjects recommended to be used on a need basis in case of acid reflux flare/heartburn
3.Change in STAI (State-Trait Anxiety Inventory) score, Profile of Mood State (POMS) questionnaire score (a. Total Mood Disturbance b. Depression),gut microbiota.
4.Change in serum cortisol levels
5.Changes in symptom score on a 7-point Likert scale to grade overall symptoms of dyspepsia. |
1.Screening, day 30 and day 60
2.Screening, day 30 and day 60
3.Screening and day 60
4.Screening, day 15 and day 60
5.Screening, day 15, 30 and day 60.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcomes are as follows-1.Assessment of adverse events, treatment compliance and tolerability of investigational products, changes in vital sign parameters. 2.Assessment of changes in complete blood count, liver function test and kidney function test |
1.Screening, baseline, day 15, day 30, day 60
2.Screening and day 60 |
|
|
Target Sample Size
|
Total Sample Size="81"
Sample Size from India="81"
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)
|
06/08/2024 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 current study focuses on clinical validation
of efficacy of nutraceutical product in relieving stress and functional
dyspepsia symptoms in adults for gut health. The effect of these
nutraceuticals not only targets the physical symptoms but also enhances overall
well-being. Improved digestive health leads to better nutrient absorption,
which is essential for energy levels and immune function. Reduced stress levels
contribute to better sleep quality, cognitive function, and emotional
stability. |