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CTRI Number  CTRI/2025/12/099275 [Registered on: 17/12/2025] Trial Registered Prospectively
Last Modified On: 01/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Study on chilli ginger extract for supporting gut health 
Scientific Title of Study   A randomized, double-blind, placebo-controlled, parallel-arm clinical trial to evaluate the efficacy and safety of chilli ginger extract in improving gut health. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/25-26/018 Version: 1.00 dated 17th September 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mandar Doiphode 
Designation  Principal Investigator 
Affiliation  Sangvi Multispeciality Hospital 
Address  Sr. No. 71/1/2/189, City survey No. 2387, Krushna Chowk, Krushna Nagar, New Sangvi, Pune, Maharashtra.

Pune
MAHARASHTRA
411027
India 
Phone  09850077168  
Fax  -  
Email  drmandar.sangvihospital@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr G Balaji  
Designation  Scientist  
Affiliation  Mane Kancor Ingredients Pvt Ltd  
Address  Angamaly, Ernakulam, KERALA, India

Ernakulam
KERALA
683573
India 
Phone  9995803488  
Fax  -  
Email  Balaji.G@MANE.com  
 
Details of Contact Person
Public Query  
Name  Dr Sherena PA  
Designation  Senior Scientist  
Affiliation  Mane Kancor Ingredients Pvt Ltd 
Address  Angamaly, Ernakulum, Kerala

Ernakulam
KERALA
683573
India 
Phone  9995869736  
Fax  -  
Email  Sherena.PA@MANE.com  
 
Source of Monetary or Material Support  
Mane Kancor Ingredients Pvt Ltd, Angamaly, Ernakulam, KERALA, India 683573 
 
Primary Sponsor  
Name  Mane Kancor Ingredients Pvt. Ltd. Angamaly, Kerala 683573  
Address  Angamaly, Kerala 683573  
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Doiphode  Sangvi Multispeciality Hospital  Ground Floor, Sr. No. 71/1/2/189, City survey No. 2387, Krushna Chowk, Krushna Nagar, New Sangvi, Pune, Maharashtra.
Pune
MAHARASHTRA 		 09850077168
-
drmandar.sangvihospital@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sangvi Multispeciality Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Gastrointestinal health 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A  one 5 g sachet containing 2.5 g of Chilli Ginger Extract powder, administered orally twice daily (morning and evening) after meals, dissolved in 100 mL of water, for a duration of 28 days. 
Comparator Agent  Group B  one 5 gm placebo powder sachet, administered orally twice daily (morning and evening) after meals, dissolved in 100 mL of water, for a duration of 28 days. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Males and females aged 20-45 years (both inclusive)
2. Participants with no history of specific diet or medication intake that could interfere with metabolic homeostasis and gut microbiota, including but not limited to oral or intravenous antibiotics, probiotics, or other microbiota-altering supplements within three months prior to recruitment.
3. Trial participants in normal health as determined by personal medical history and clinical examination including vital signs.
4. Participants willing and able to maintain a habitual, balanced diet throughout the study period and providing voluntary, written informed consent to participate in the study. 
 
ExclusionCriteria 
Details  1. Participants with a diagnosis of colonic inertia.
2. Participants with a history of surgical interventions within the last six months.
3. History of anorectal surgery.
4. Participants diagnosed with functional gastrointestinal disorders, including Functional Constipation, Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (IBD), or chronic diarrhea.
5. Participants with structural abnormalities such as rectal prolapse, rectocele, or anorectal stricture.
6. Participants with untreated or uncontrolled systemic conditions and comorbidities.
7. A medical history of hypothyroidism, Grade 2 obesity, morbid obesity, or constipation associated with premenopausal or postmenopausal status.
8. Participants using antibiotics, probiotic products, herbal supplements, dietary fiber, or phytonutrient supplements.
9. Participants following an abnormal or restrictive dietary pattern (e.g., low sodium, fasting, ketogenic, or high-protein diets) during the four weeks preceding enrollment or unwilling to maintain a normal, balanced diet during the study period.
10. Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study.
11. Participants with a history of substance abuse or heavy use of alcohol and drugs or tobacco use, where participants smoke more than 1/2 pack per day. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Assessing Gut health using a Gastrointestinal Symptom Rating Scale (GSRS) score.
2. Stool Consistency and Frequency:
• Bristol Stool Form Scale (BSFS): Evaluating stool consistency.(A BSFS chart will be provided to the participant for reference).
• Frequency of Bowel Movements: Self-reported daily bowel movements recorded using a bowel diary.
•Time of Evacuation: Documenting the duration of each bowel movement using a bowel diary.
3. Gut microbiome modulation by studying whole-genome shotgun metagenomic sequencing of stool samples.
4.Short chain fatty acid analysis in the stool samples. 		 1. at baseline, day 14, and 28
2. at baseline, day 14, and day 28
3. baseline and day 28
4. baseline and day 28. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Adverse events
Gastrointestinal symptoms occurring on non-visit days will be recorded as anticipated adverse events. Non-GI adverse events will be recorded daily. All adverse events will be documented in the adverse event section of the case report form (CRF).
2. Compliance will be assessed.
3. Tolerability of the investigational product.
 		 1. at baseline, day 14, and day 28.
2. at day 28.
3. at day 14 and day 28.
 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   26/12/2025 
Date of Study Completion (India) 02/02/2026 
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  

Functional gastrointestinal disorders (FGIDs) are common conditions that affect digestive comfort, gut motility, and overall well-being. Many individuals experience symptoms such as bloating, abdominal discomfort, and irregular bowel habits, often without identifiable structural abnormalities. Current management options provide limited long-term relief, leading to growing interest in safe, food-based approaches that support digestive health.

This study is designed to evaluate the safety and efficacy of a natural, standardized formulation intended to support gut comfort and digestive function in adults with FGID-related symptoms. The trial will assess gastrointestinal outcomes, patient-reported symptoms, and overall well-being over the intervention period. The findings are expected to contribute to evidence supporting non-pharmacological strategies for general digestive health.

 
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