| CTRI Number |
CTRI/2025/03/082201 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trial to study effectiveness and safety of Mool Healths customized Gut Health Regimen in participants with symptoms of Gas and Bloating. |
|
Scientific Title of Study
|
Evaluation of the Effectiveness and Safety of Mool Healths customized Gut Health Regimen in participants with symptoms of Gas and Bloating - A Double-Blind Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Doiphode Mandar Vijay |
| Designation |
Gastrointestinal Endosurgeon |
| Affiliation |
Punawale Multispecialty Hospital |
| Address |
Punawale Multispecialty Hospital, S.No 11/2/4, Alpha Heights, Vishnu Dev Nagar, Punawale, Pune, Pimpri-Chinchwad
Pune
MAHARASHTRA
411033
India |
| Phone |
9850077168 |
| Fax |
|
| Email |
dr.mandardoiphode9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Syed Atif Hussain |
| Designation |
AVP, Clinical Operations |
| Affiliation |
Strider Lifesciences Pvt Ltd |
| Address |
1005, 10th Floor, B Wing, Express Zone, Off WEH, Malad East
Mumbai
MAHARASHTRA
400097
India |
| Phone |
9901610610 |
| Fax |
|
| Email |
syedatif.hussain@striderdct.com |
|
Details of Contact Person
Public Query
|
| Name |
Syed Atif Hussain |
| Designation |
AVP, Clinical Operations |
| Affiliation |
Strider Lifesciences Pvt Ltd |
| Address |
1005, 10th Floor, B Wing, Express Zone, Off WEH, Malad East
Mumbai
MAHARASHTRA
400097
India |
| Phone |
9901610610 |
| Fax |
|
| Email |
syedatif.hussain@striderdct.com |
|
|
Source of Monetary or Material Support
|
| Tatvartha Health Private Limited
C-7, 67/P, Fortune Hotel Galaxy, N. H. No 8, Koparli Road, GIDC NA, Vapi, Valsad – 396195, Gujarat |
|
|
Primary Sponsor
|
| Name |
Tatvartha Health Private Limited |
| Address |
C-7, 67/P, Fortune Hotel Galaxy, N. H. No 8, Koparli Road, GIDC NA, Vapi, Valsad – 396195, Gujarat |
| Type of Sponsor |
Other [Ayurvedic and Nutraceutical] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mandar Vijay Doiphode |
Punawale Multispecialty Hospital |
S.No 11/2/4, Alpha Heights, Vishnu Dev Nagar, Punawale, Pune, Pimpri-Chinchwad
Pune
MAHARASHTRA |
9850077168
dr.mandardoiphode9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Skinovate Independent 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 |
1.Ayurvedic supplement which aids in Gas & Bloating (Cumin, Fennel, Long Pepper)
2.Ayurvedic supplement for mild Constipation (Avipattikar Churna, Triphala Churna)
3.Ayurvedic supplement for improved Bowel Movement (Guduchi, Sonth, Piper Longum)
4.Ayurvedic supplement for better Mood & Sleep (Brahmi, Ashwagandha, Tagar).
5.Probiotic (Bacillus coagulans) |
1.Ayurvedic supplement which aids in Gas & Bloating: supports digestion, relieves gas and bloating, and detoxifies the gut.
2.Ayurvedic supplement for mild Constipation: regulates bowel movements and detoxifies the digestive tract.
3.Ayurvedic supplement for improved Bowel Movement: enhances digestion, reduces bloating, and balances doshas for gut health.
4.Ayurvedic supplement for better Mood & Sleep: Reduces stress, promotes sleep, and supports gut-brain balance for digestive health.
5.Probiotic which targets Gas, Bloating, and IBS at the root: targets root causes of gut issues like gas, bloating, and IBS. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Males/females of age of 18 years and 65 years.
2.Patients with self-reported or physician-confirmed symptoms of Gas and Bloating for minimum 2 weeks and currently experiencing at least 2 or more of the following symptoms:
a Abdominal pain
b Heartburn
c Burning Sensation
d Acid regurgitation
e Sucking sensations in the epigastrium
f Persistent or recurrent nausea or vomiting
g Borborygmus
h Abdominal distension
i Eructation (Burping)
j Increased flatus
k Constipation
l Diarrhoea
m Change in frequency of bowel movements
n Weight loss
3.Participants who can and are willing to provide written Informed Consent.
4.Participants who are willing to follow dietary instructions.
5.Female participant of child-bearing potential must agree to practice a medically acceptable method of birth control during the study period.
6.Participants must agree not to undergo any other type of treatment or procedure for his or her current condition during the study. |
|
| ExclusionCriteria |
| Details |
1. Participant with a known history of allergy to any of the ingredients of the nutraceutical regimen or history or presence of multiple severe allergies.
2. Female participant who is pregnant or planning pregnancy during the study period or breastfeeding.
3. Participants with diagnosed severe gastrointestinal disorders like IBS history of inflammatory bowel disease haemorrhoids active peptic ulcer disease or gastric outlet obstruction celiac disease colorectal cancer malignancies or others.
4. Participant with history of significant surgeries affecting gastrointestinal function within the past six months.
5. Active gastrointestinal ulcers or a recent history of peptic or duodenal ulcers.
6. Hepatic disorders or fatty liver disease.
7. Participant with skin disorders related to immune function such as seborrheic dermatitis
8. Participant with history of previous treatment with test product within the past four months.
9. Participant having a mental or physical condition that would in the opinion of the Investigator place the participant at an unacceptable risk or render the participant unable to meet the requirements of the protocol or interfere with the ability to provide consent or complete study requirements.
10. Participant with a history of participation in another clinical study involving an investigational product within the past three months prior to the start of this study or planning participation in another clinical trial during the current study duration.
11. Participant with a history of Acute or Chronic illness that may compromise immune function or overall health and other severe debilitation conditions like uncontrolled diabetes renal insufficiency hepatic impairment or any life-threatening conditions.
12. History or concurrent use of antacids probiotic prebiotics digestive enzymes medications or supplements for constipation that significantly alter gastrointestinal motility or other nutraceuticals targeting Gas and Bloating or interfere with gastrointestinal function within two weeks prior to enrollment into the study.
13. Participant having or has received antibiotics anti-inflammatory drugs or any other substance known to increase the gastrointestinal symptoms from ten days prior to study enrolment and during the study duration.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess change in Gas and Bloating symptoms as measured by the PI adapted GSRS Score |
From baseline to week 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Evaluate change in Gas and Bloating symptoms as measured by the PI adapted GSRS Score.
2.Assess changes in quality of life by evaluating stress levels and sleep patterns, as recorded in PI adapted GSRS Score.
3.Assess the Adverse Events profile reported with Mool Healths customized Gut Health Regimen in participants with symptoms of Gas and Bloating. |
From baseline to week 4. |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
24/03/2025 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
This is a prospective, double-blind, clinical study designed to evaluate
the clinical effectiveness and safety of Mool Health’s customized Gut Health
Regimen in participants experiencing symptoms of Gas and Bloating. The study
will be conducted over a 28-day intervention period.
Eligible
participants, aged 18 to 65 years, experiencing self-reported or PI diagnosed
symptoms of Gas and Bloating, will be screened for inclusion and exclusion
criteria. Following the signing of informed consent, participants will undergo
a symptom evaluation conducted by the Principal Investigator (PI) using the PI
Symptom Evaluation Form, the Online Symptom
Evaluation Form and
the PI adapted Gastrointestinal
Symptom Rating Scale GSRS. Participants meeting the
eligibility criteria will be assigned Mool Health’s customized Gut Health
Regimen based on the PI’s clinical evaluation, the participant’s online symptom
profile, and an algorithm-based software designed by study sponsor to ensure
consistent and accurate customization. The regimen will include one or more
combination of ayurvedic and nutraceutical products aimed at alleviating Gas
and Bloating symptoms.
Participants will follow the regimen for 28 days,
with study assessments scheduled at five key time points. These include a
screening visit, during which symptom evaluations and baseline assessments are
performed; a kit dispensing visit for regimen assignment and participant
education, which may occur on the same day or within 48 hours of screening; and
weekly follow-up visits on Days 7, 14, and 21 to monitor symptom progression,
compliance and adverse events. The final visit on Day 28 will serve as the end-of- study
assessment to evaluate the overall effectiveness of the intervention and
monitor adverse events. Throughout the study, a double-blind design ensures
that neither the participants nor the Investigators are aware of the specific
regimen composition, minimizing bias in outcome assessment. |