A clinical study to study the effect of a herbal formulation in patients with diarrhoea in comparison with oral rehydration therapy
- Conditions
- Health Condition 1: K928- Other specified diseases of the digestive systemHealth Condition 2: null- Patients with mild to moderate diarrhoea
- Registration Number
- CTRI/2018/03/012699
- Lead Sponsor
- Clinfound Clinical Research Services PvtLtd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
1.Onset of diarrhoea within 24 hours.
2.At least three loose stools recorded within the 24 hours before preceding randomization.
3.At least one of the following signs and symptoms of enteric infection
(a)Abdominal pain or cramps
(b)Vomiting
(c)Faecal urgency
4)The patient agreed to the study protocol and the schedule of clinical and follow-up, and provided informed, written consent
1)Pregnant, breast feeding, or planning a pregnancy
2)Presence of blood in stool, Clinical findings suggesting moderate or severe dehydration.
3)Immediately prior to randomization, acute diarrhoea for > 72 hours (No change or improvement in condition for 72 hours).
4)Administration of any of the anti-diarrhoeal allopathic drug from the onset of diarrhoea.
5)Active, uncontrolled, or clinically significant diseases or disorders of the heart, lung, kidney, GI tract, or central nervous system.
6)Known to have AIDS or HIV positive.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method DIARRHOEA QUESTIONNAIRETimepoint: Day1,Day2,Day3,Day4
- Secondary Outcome Measures
Name Time Method Adverse EventsTimepoint: Day1,Day2,Day3,Day4;STOOL MICROSCOPYTimepoint: Day1,Day4