| CTRI Number |
CTRI/2024/05/067859 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic
Other (Specify) [As per the protocol design] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to evaluate the Safety and Efficacy of ORS of Mystical Biotech Pvt Ltd versus traditional marketed ORS in subjects with Diarrhea |
|
Scientific Title of Study
|
Prospective, Randomized, Comparative, Parallel Group, Study to evaluate the Safety and Efficacy of ORS of Mystical Biotech Pvt Ltd versus Traditional marketed ORS in subjects with Diarrhea |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ORS/MYS/OBS/2024, V 1.0,21FEB2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nutan Kumar Agrawal |
| Designation |
Professor |
| Affiliation |
MLB Medical college |
| Address |
Department of Medicine, MLB medical college,Jhansi,
Jhansi
UTTAR PRADESH
284128
India |
| Phone |
9839789378 |
| Fax |
|
| Email |
dr_nutan_agrawal@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Antaryami Maharana |
| Designation |
Head-Medical Affairs |
| Affiliation |
Abiogenesis Clinpharm Private Limited |
| Address |
2nd Floor, Plot No. 69, D No. 8-2-248/1/7/69,
Nagarjuna Hills, Punjagutta,
Hyderabad
TELANGANA
500082
India |
| Phone |
7702186021 |
| Fax |
|
| Email |
antaryami@abiogenesisclinpharm.com |
|
Details of Contact Person
Public Query
|
| Name |
Bridreth khokhare |
| Designation |
Manager |
| Affiliation |
M/s. Mystical Biotech Pvt Ltd |
| Address |
#64, 3rd Floor, Shri Complex, 1st Main, Dr Rajkumar Rd, Extension, 2nd Block, Rajajinagar
Bangalore
KARNATAKA
560010
India |
| Phone |
9538740394 |
| Fax |
|
| Email |
mysticalbiotech@gmail.com |
|
|
Source of Monetary or Material Support
|
| M/s. Mystical Biotech Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Ms Mystical Biotech Pvt Ltd |
| Address |
#64, 3rd Floor, Shri Complex, 1st Main, Dr Rajkumar Rd, Extension, 2nd Block, Rajajinagar, Bengaluru-560010, Karnataka |
| 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 Nutan Kumar Agrawal |
Maharani Laxmi Bai medical college |
Department of medicine, MLB medical college, Jhansi, UP-284128
Jhansi
UTTAR PRADESH |
9839789378
dr_nutan_agrawal@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maharani Laxmi Bai Medical College and Associated Hospital |
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, (2) ICD-10 Condition: R198||Other specified symptoms and signsinvolving the digestive system and abdomen, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Marketed ORS |
Dose: 4.4 gm, route of administration: Oral, frequency: As per PI discretion, Duration of therapy: Up to 6 days |
| Intervention |
ORS (Intervention made by Mystical Biotech Pvt Ltd.) |
Dose: 2.3 gm, route of administration: Oral, frequency: 2 sachets per day, Duration of therapy: Up to 6 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Participants of either gender, aged 18-60 years (both inclusive).
2.Willing to comply with the study procedures and provide written informed consent.
3.Acute diarrhea, defined as the passage of three or more loose or watery stools in a 24-hour period, lasting for less than 72 hours.
4.Ability to provide informed consent. |
|
| ExclusionCriteria |
| Details |
1.Chronic diarrhea (lasting for more than 72 hours).
2.Presence of severe dehydration requiring immediate intravenous fluid replacement.
3.Known hypersensitivity to any components of the investigational ORS or traditional marketed ORS.
4.History of significant gastrointestinal diseases (e.g., inflammatory bowel disease, irritable bowel syndrome).
5.Use of antibiotics or any anti-diarrhoeal medication in the previous 2 weeks.
6.Use of pre-/probiotics in the previous 1 week
7.Participation in another clinical trial within the past 30 days.
8.Underlying severe medical conditions (e.g., renal, cardiac, hepatic) that could affect hydration status or complicate assessment of study outcomes.
9.Use of medications that could interfere with the study outcomes (e.g., antidiarrheal drugs).
10.Any other medical condition or circumstance that, in the opinion of the investigator, would compromise the safety or compliance of the subject or the quality of the data.
11.Participants who are pregnant, breastfeeding, or planning to become pregnant during the study period. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of subjects with resolution of dehydration after initiating ORS treatment until end of study treatment. |
Baseline to EOT(up to 6days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the time to resolution of diarrhea symptoms between the investigational ORS and traditional marketed ORS.
To assess subject satisfaction and preference for the investigational ORS versus traditional marketed ORS.
To analyze the frequency of adverse events and adverse reactions between the two treatment groups. |
baseline to Day 9 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
03/06/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This Observational study
clinical study is designed as a prospective, randomized, comparative study, that
aims to evaluate the safety and efficacy of ORS in comparison to a Traditional
Marketed ORS in subjects diagnosed with acute diarrhea. The trial will adopt a
parallel-group design and will be conducted across multiple clinical centres. A
total of 60 eligible subjects diagnosed with acute diarrhea will be enrolled.
Subjects will be randomized in a 3:1 ratio, with 45 subjects assigned to the
intervention group receiving ORS and 15 subjects allocated to the comparator
group receiving Traditional Marketed ORS. Subjects in the intervention arm will
be administered ORS in accordance with recommended dosing guidelines. Subjects
in the comparator arm will receive Traditional Marketed ORS, following the
dosing instructions provided by the manufacturer. All enrolled subjects,
regardless of their assigned treatment group, will receive the established
standard of care for diarrhea management. This includes guidance on dietary
modifications and the provision of supportive care as needed. |