CTRI/2018/03/012699Completed未知
A randomized, parallel group, open label study to evaluate theeffect of herbal antidiarrheal formulation CKCD-001 compared withORS solution on patients with mild to moderate Diarrhoea.
Clinfound Clinical Research Services PvtLtd0 sites100 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Investigators
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