Efficacy and Safety of Salol et Menthol Mixture versus Oral Rehydration Salts (ORS) Solution for Treatment of Patients with Acute Watery Diarrhea; An Observer-Blinded, Randomized Controlled, Pilot Study
- Conditions
- Patients with Acute Watery DiarrheaAcute Watery Diarrhea, Salol et Menthol Mixture
- Registration Number
- TCTR20221007001
- Lead Sponsor
- Boss Pharmacare Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 30
1.Thai Male/Female (should balance in both gender) age between 18-55 years.
2.Presenting with acute watery diarrhea (defined as 3 or more watery stools (BSFS 6-7) per day) for not more than 72 hours.
3.Presenting with at least two or more associated symptoms including flatulence, upset stomach and abdominal pain
4.Have the ability to understand the requirements of the study and must voluntarily sign and date an informed consent, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to the initiation of any screening or study-specific procedures
1.Known or suspected hypersensitivity to phenyl salicylate (salol) and menthol.
2.Patient has a history of any illness that, in the opinion of principal investigator or designated physicians, might confound the result of the study or pose an additional risk in administering treatment to the patient. This may include but is not limited to: a history of relevant drug or food allergies; history of cardiovascular, gastrointestinal, central nervous system disease, renal and hepatic impairment; history or presence of clinically significant illness; or history of mental illness that may affect compliance with study requirements.
3.Suffering from diarrhea as a result of antibiotic treatment, food allergies, ingestion of laxatives (72 hours prior to this assessment)
4.Presenting symptoms of irritable bowel syndrome (IBS)
5.Presenting body temperature more than 38.5 C; antipyretic medication should not have been administered in the 6 hours prior to this assessment)
6.Presenting with grossly/mucous bloody stool
7.Presenting with moderate or severe dehydration (i.e. symptoms of hypovolemia such as orthostatic hypotension, dizziness or wrinkling of skin)
8.Administration of anti-diarrhea product including antibiotics and drug that affect the gastrointestinal tract for this diarrhea episode (e.g. prokinetic drug and anticholinergic drug)
9.Treatment with investigational product within 30 days before screening
10.Participation in any investigation drug study within 1 month from screening (from the last follow-up visit to the screening)
11.Pregnancy (confirmed by interviewing)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of diarrhea in hours Study Day 0 Time from the treatment initiation to recovery,Improvement in frequency and consistency of stools Study Day 0 and Study Day 1-6 Bristol Stool Form ,Improvement from baseline of diarrhea associated symptoms Study Day 0 and Study Day 1-6 visual analogue scales (VAS)
- Secondary Outcome Measures
Name Time Method The incidence of adverse events Study Day 0 and Study Day 7 physical examination, vital sign and clinical laboratory assessment