S.No 11/2/4, Alpha Heights, Vishnu Dev Nagar, Punawale, Pune, Pimpri-Chinchwad, Maharashtra
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.
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.
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
Name
Address
NIL
NIL
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
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: K318||Other specified diseases of stomach and duodenum,
Intervention / Comparator Agent
sno
Intervention/Comparator
Type
Drug-Type
Procedure Name
Details
1
Intervention Arm
Drug
Other than Classical
(1) Medicine Name: Acid Soothe, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Not available), Additional Information: Not available(2) Medicine Name: Stress less, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Not available), Additional Information: Not available(3) Medicine Name: Digest Ease, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 520(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Not available), Additional Information: Not available(4) Medicine Name: Consticare, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 525(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Not Available), Additional Information: Not available(5) Medicine Name: Acid Ease , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 225(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Not Available), Additional Information: Not available
Intervention
1. Ayurvedic supplement to restore Acid Balance (Sonth, Marich and Pippali).
2. Ayurvedic supplement for Mild Constipation (Avipattikar Churna, Triphala Churna).
3. Ayurvedic supplement to improved Bowel Movements (Guduchi, Sonth, Piper Longum)
4. Ayurvedic supplement to better Mood & Sleep (Brahmi, Ashwagandha, Tagar)
5.Probiotic to Calm Your Acidity, Heal Your Gut: (Bacillus coagulans)
1. Ayurvedic supplement that restores Acid Balance: neutralizes excess stomach acid and soothes the digestive tract. It relieves acidity, heartburn, and indigestion while promoting proper digestion and detoxification for long-term gut health.
2. Ayurvedic supplement for Mild Constipation: alleviates mild constipation by addressing digestive imbalances. It alleviates mild constipation, regulates bowel movements, and detoxifies the digestive tract.
3. Ayurvedic supplement for improved Bowel Movement: addresses the root causes of digestive issues by balancing the body’s digestive system. It 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 to calm your Acidity, Heal Your Gut: relieves acidity, heartburn, and bloating while restoring gut balance and improving digestion. It supports long-term gut health and prevents acidity recurrence.
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. 2. Patients with self-reported or physician-confirmed symptoms of Acidity for a minimum 2 weeks and currently experiencing at least 2 or more of the following symptoms:
a) Heartburn
b) Burning sensation
c) Regurgitation
d) Nausea/ vomiting
e) Burping
f) Bloating
g) Sour / bitter taste
h) Difficulty swallowing
i) Chest pain
j) Coughing
k) Hoarseness
l) Diarrhoea
m) Headache
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/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.Participant with history of significant surgeries affecting esophageal or gastric function within the past 6 months.
4. Participant with active gastrointestinal ulcers or a recent history of peptic or duodenal ulcers.
5.Participant with hepatic disorders or fatty liver disease.
6.Participant with skin disorders related to immune function, such as seborrheic dermatitis
7.Participant with history of previous treatment with test product within the past 4 months.
8.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.
Method of Generating Random Sequence
Other
Method of Concealment
Other
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
To assess change in Acidity symptoms as measured by the PI adapted GSAS Score.
From baseline to Week 4.
Secondary Outcome
Outcome
TimePoints
1. To evaluate change in Acidity symptoms as measured by the PI adapted GSAS Score.
2. To assess changes in quality of life by evaluating stress levels and sleep patterns, as recorded in PI adapted GSAS Score.
3. To assess the Adverse Events profile reported with Mool Health s customized Gut Health Regimen in participant with symptoms of Acidity
From baseline to Week 4.
Target Sample Size
Total Sample Size="38" Sample Size from India="38" Final Enrollment numbers achieved (Total)= "38" Final Enrollment numbers achieved (India)="38"
Phase of Trial
Post Marketing Surveillance
Date of First Enrollment (India)
11/04/2025
Date of Study Completion (India)
21/05/2025
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="0" Months="4" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Completed
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 Acidity.
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 Acidity, 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 Formand the PI adaptedGastroesophageal Reflux Disease Symptom Assessment Scale (GSAS). 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 Acidity
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.