| CTRI Number |
CTRI/2025/11/097325 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To check if Dioctahedral Smectite sachets are safe and work well for treating sudden diarrhea. |
|
Scientific Title of Study
|
A Prospective, Randomized, Multicenter, Double-blind, Parallel-group, Placebo-controlled Study to Compare Efficacy and Safety of Dioctahedral Smectite Plus Sachets versus Placebo Sachets in Treatment of Subjects with Acute Diarrhea |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CT-072-DISM-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashish Mungantiwar |
| Designation |
Executive President Medical Services and Head Clinical Trials |
| Affiliation |
Macleods Pharmaceuticals |
| Address |
Macleods pharmaceuticals Ltd R and D III plot No 18 street No 9 Marol MIDC Andheri East Mumbai (Suburban) MAHARASHTRA 400093 india
Mumbai (Suburban)
MAHARASHTRA
400093
India |
| Phone |
02248890100 |
| Fax |
|
| Email |
drashish@macleodspharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Mungantiwar |
| Designation |
Executive President Medical Services and Head Clinical Trials |
| Affiliation |
Macleods Pharmaceuticals |
| Address |
Macleods pharmaceuticals Ltd R and D III plot No 18 street No 9 Marol MIDC Andheri East Mumbai (Suburban) MAHARASHTRA 400093 india
Mumbai (Suburban)
MAHARASHTRA
400093
India |
| Phone |
02248890100 |
| Fax |
|
| Email |
drashish@macleodspharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Shrivastava |
| Designation |
Head of Clinical Oprations |
| Affiliation |
Macleods Pharmaceuticals |
| Address |
Macleods pharmaceuticals Ltd R and D III plot No 18 street No 9 Marol MIDC Andheri East Mumbai (Suburban) MAHARASHTRA 400093 india
Mumbai (Suburban)
MAHARASHTRA
400093
India |
| Phone |
02248890100 |
| Fax |
|
| Email |
priyankas@macleodspharma.com |
|
|
Source of Monetary or Material Support
|
| Macleods Pharmaceuticals Ltd |
|
|
Primary Sponsor
|
| Name |
Macleods Pharmaceuticals Ltd |
| Address |
Macleods Pharmaceuticals Ltd, 3rd floor, Atlanta Arcade, Church Road, near Leela hotel, Andheri Kurla road, Andheri east, Andheri India - 400059 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Macleods Pharmaceuticals Ltd |
Macleods Pharmaceuticals Ltd |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Milan Dhaduk |
Global Hospital |
Global Hospital, OPD:1,4th Floor, Beside Navjivan, Sarthana Jakatnaka, Surat- 395006, Gujarat, India
Surat
GUJARAT |
8866683338
drmilandhadukcr@gmail.com |
| Dr Varsha Yogesh Godbole |
GMERS Medical College & Hospital |
Department Of Medicine ,7th floor hospital building GMERS Medical College & Hospital, Gotri Vadodara, Gujarat-390021.
Vadodara
GUJARAT |
9879181673
drvgodbole@gmail.com |
| Dr Ramanbhai Gamabhai Patel |
Namostute Hospital |
Namostute Hospital
Plot no-1285, Sector 6-D, GH-3 Circle, Opposite Civil Hospital, Gandhinagar-382006, Gujarat, India
Gandhinagar
GUJARAT |
9898205641
drramanpatel22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Global Ethics Committee |
Approved |
| IEC Shashvat Surgicare Hospital |
Approved |
| Institutional Human Ethics Committe GMERS Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R197||Diarrhea, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparator: Placebo sachets
|
Dosage form and dose strengths: Solid oral
dosage form (Sachets), Placebo 3 g |
| Intervention |
Test product: Dioctahedral Smectite Plus
Sachets
|
Dosage form and dose strengths: Solid oral
dosage form (Sachets); Dioctahedral Smectite
3 g |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
A subject must fulfill all of the inclusion criteria to be enrolled in the study
1. Male and females between 18-65 years (both ages inclusive)
2. Subject has a diagnosis of acute diarrhea presumed of infectious origin, defined as
The passage of 3 or more unformed loose or watery stools (rated according to the Bristol scale) per day without associated alarm symptoms marked with asterisk in the exclusion criteria
Having started within 48 hours before Visit 1 (first study drug intake time).
3. Subject has, usually, normal bowel habits, (Rome III criteria), that is at least 3 stools per week and no more than 3 stools per day
4. Subjects willing and able to comply to protocol-defined study procedures
5. Subjects willing to voluntarily give their written informed consent to participate in the study
Symptoms considered as alarm symptoms are identified in the exclusion criteria (1)
Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional Bowel Disorders. Gastroenterology 2006,131:1480 91. |
|
| ExclusionCriteria |
| Details |
subject must not fulfill any exclusion criteria to be enrolled in the study:
Exclusion related to acute diarrhea episode
1. At least one of the following alarm symptoms as per ROME III criteria
i). Bloody diarrhea
ii). Pus in the stools
iii). Fever grater than or equal to 38.0 degree celsius (That is grater than or equal to 100.4 degree fahrenheit)
iv). Moderate or severe dehydration according to World Health Organisation (WHO) definition, requiring intravenous (IV) rehydration,
v). Repeated vomiting
vi). Persistent abdominal pain
These symptoms are considered as alarm symptoms
2. Other episode of acute watery diarrhea within the previous 30 days,
3. Persistent diarrhea, defined as acutely starting episode of diarrhea lasting more than 14 days
4. History of chronic diarrhea (Rome III criteria); i.e. 3 or more loose or watery stools per day for at least 12 weeks, consecutive or not, in the preceding 12 months
5. Travellers diarrhea defined as a diarrheal episode due to contamination experienced by subjects having travelled in at risk countries, or coming from abroad and experiencing locally an acute diarrhea episode, occurring usually within the first 2 weeks of the stay in a foreign environment.
6. Diarrhea suspected to be induced by any medication drug (example antibiotic therapy, including Clostridium difficile-induced diarrhea, within 1 week before entry in the study, laxative agent, thyroid hormone (at a nonstabilised dosing), colchicine intake, etc.)
7. Anti-diarrheal medication intake during the last month or currently on medication which is known to cause diarrhea
8. Any subject requiring repeated intake of a drug with a narrow therapeutic margin (for example, digoxin, theophylline, etc.)
9. History of hypersensitivity to dioctahedral smectite or its excipients or placebo components,
10. Subject currently receiving or and in the opinion of the investigator likely to require treatment during the study with drugs that are not permitted by the study protocol (for example, antibiotic agents, anti-diarrheal agents, antiemetic drug, antispasmodic drug, etc.) during the study
11. Subjects use of any investigational medication or participation in the clinical trial within the last 30 days before entering this study
12. History of gastric or intestinal resection, or vagotomy
13. Known digestive malabsorption disease, including coeliac disease
14. Any suspicion of abdominal surgery needed during study period
15. Known inflammatory bowel disease.
16. Known Human immunodeficiency virus (HIV) positive status
17. Known or suspected immunosuppression
18. Known severe renal or hepatic insufficiency
19. History of, or known current, problems with alcohol abuse and or known drug addict),
20. Have participated in any other clinical trial within 1 month prior to screening visit
21. Any mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and or evidence of an uncooperative attitude
22. Pregnant or lactating women.
23. Female of childbearing potential not willing to use adequate and consistent method of contraception during entire study period
24. Any clinically significant medical and or surgical condition or a laboratory abnormality that, in the opinion of the investigator, would put the subject at risk through study period, or would affect the study analyses or protocol compliance if the disease exacerbates during the study; and would make the subject unsuitable to be enrolled in the study as per investigators opinion |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time to recovery, defined as time from the 1st study treatment intake to the first formed stool followed by a
non watery stool. Consistency will be rated according to the Bristol scale. (Test product versus Placebo) |
Day 5, day 9 from study treatment dispense |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Efficacy Endpoints
Abdominal pain intensity (rated with a 4-point ordinal scale 1 is equal to mild, 2 is equal to moderate, 3 is equal to severe, 4 is equal to very severe) per 12hour period after 1st study treatment intake
Time (hours, minutes) from diarrhea onset to recovery defined as first formed stool followed by a non-watery stool from the 1st study treatment intake
Time (hours, minutes) from first watery stool to the first formed stool from the 1st study treatment intake
Time (hours, minutes) from the 1st study treatment intake to the last watery stool
Number of stools, per 12-hour period from the 1st study treatment intake
Number of watery stools, per 12-hour period from the 1st study treatment intake
Percentage of subjects with associated symptoms such as nausea, vomiting, abdominal pain, and anal irritation, per 12-hour period after 1st study treatment intake |
day 5, day 9 from study treatment dispense |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
22/11/2025 |
| 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
|
Prospective, Randomized, Multicenter, Double-blind, Parallel-group, Placebo-controlled Study to Compare Efficacy and Safety of Dioctahedral Smectite Plus Sachets versus Placebo Sachets in Treatment of Subjects with Acute Diarrhea |