| CTRI Number |
CTRI/2025/08/093264 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of herbal medicine on digestive disorder |
|
Scientific Title of Study
|
A Non-randomized, Single-Arm, Open-Label Pilot Study to Evaluate the Efficacy and Safety of MOLEQURE- Gastrointestinal Health in Adults with Functional Gastrointestinal Disorder |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Srikanta Pandit |
| Designation |
Professor and Head, Department of Kayachikitsa |
| Affiliation |
J. B. Roy State Ayurvedic Medical College and Hospital |
| Address |
Centenary Heritage Building, Research Unit, Clinical Trial Room 301-302,Raja Dinendra Street, Kolkata
Kolkata
WEST BENGAL
700004
India |
| Phone |
09831723650 |
| Fax |
|
| Email |
srikantapandit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Srikanta Pandit |
| Designation |
Professor and Head, Department of Kayachikitsa |
| Affiliation |
J. B. Roy State Ayurvedic Medical College and Hospital |
| Address |
Centenary Heritage Building, Research Unit, Clinical Trial Room 301-302,Raja Dinendra Street, Kolkata
WEST BENGAL
700004
India |
| Phone |
09831723650 |
| Fax |
|
| Email |
srikantapandit@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Manik Chaudhuri |
| Designation |
Senior Consultant Projects and Business Operations |
| Affiliation |
BIORADIAN, LIFESCIENCE |
| Address |
7/1 ABG Layout, 5th Cross, 1st Main, Saraswathipuram, Nandini Layout, Bengaluru
KARNATAKA
560096
India |
| Phone |
9738651205 |
| Fax |
|
| Email |
mc.bioradian@gmail.com |
|
|
Source of Monetary or Material Support
|
| AMBITN LIFESCIENCES
Door No 130, Mooppil House, Mangattri,
Tirur, Mallappuram, Kerala, India, Pin 676105
|
|
|
Primary Sponsor
|
| Name |
AMBITN LIFESCIENCES |
| Address |
Door No 130, Mooppil House, Mangattri,
Tirur, Mallappuram, Kerala, India, Pin 676105
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Srikanta Pandit BAMS MDAy PhD Ay |
Research Unit J. B. Roy State Ayurvedic Medical College & Hospital |
Centenary Heritage Building,
Research Unit
Clinical Trial Room No. 301-302, 170-172 Raja Dinendra Street, Kolkata 700004, West Bengal
Kolkata
WEST BENGAL |
09831723650
srikantapandit@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K319||Disease of stomach and duodenum, unspecified. Ayurveda Condition: MANDAGNI-DURBALAYOHÂ ANUVASANAVYAPADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: MOLEQURE- Gastrointestinal Health capsule , Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information: Zingiber officinale, Glycyrrhiza glabra, and Punica granatum extract in equal ratio |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult male and female subjects aged above 18 years with clinical diagnosis of Functional Gastrointestinal Disorder (FGID).
2. Subjects with mild to moderate gastrointestinal clinical symptoms, based on a GSRS.
3. Subjects with stable dietary and lifestyle patterns for the last 4 weeks
4. Willingness to comply with study procedures and provide written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Use of antibiotics, probiotics, prebiotics, or GI-targeting supplements in past 4 weeks
2. Subjects with organic GI diseases (IBD, celiac disease, peptic ulcer disease, GI malignancy)
3. History of gastrointestinal surgery within the past year
4. Severe psychiatric illness or any systemic disease deemed unsafe by the investigator
5. Pregnant or lactating women, or women planning to become pregnant during the study period.
6. Known allergy or hypersensitivity to any component of the investigational product
7. Use of any medications, supplements, or herbal products specifically intended for the treatment or management of liver disorders within the last 30 days.
8. Participation in any other clinical trial within 30 days prior to the screening visit.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in composite GI symptom score using a GSRS from baseline to different study visits. |
28 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1) Mean change in the Gastrointestinal Quality of Life Index (GI-QoLI) from baseline to end of the study. |
28 days. |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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="1"
Months="0"
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 primary objective is to evaluate the efficacy of MOLEQURE-Gastrointestinal Health in improving gastrointestinal symptoms such as abdominal bloating, indigestion, acidity, discomfort, altered appetite, and bowel irregularity after 28-days of 24 patients who are under clinical diagnosis of Functional Gastrointestinal Disorder (FGID). The mean change in the composite GI symptom score using a GSRS, the Gastrointestinal Quality of Life Index (GI-QoLI), and laboratory safety parameters (CBC, liver, and kidney function tests) will be assessed after 28 days of treatment with MOLEQURE-Gastrointestinal Health Capsule, twice daily before meals. The statistical analysis for this study will include descriptive statistics to summarize demographic and baseline characteristics of the participants. Within-group comparisons of efficacy variables will be conducted using paired t-tests or Wilcoxon signed-rank tests, depending on the data distribution and study time points. Adverse events and other categorical data will be analyzed using frequency and percentage distributions. A p-value of <0.05 will be considered statistically significant. |