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A clinical study to study the effect of a herbal formulation in patients with diarrhoea in comparison with oral rehydration therapy

A randomized, parallel group, open label study to evaluate the effect of herbal antidiarrheal formulation CKCD-001 compared with ORS solution on patients with mild to moderate Diarrhoea.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/03/012699
Enrollment
100
Registered
2018-03-21
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K928- Other specified diseases of the digestive system Health Condition 2: null- Patients with mild to moderate diarrhoea

Interventions

Intervention1: CHCD.01 powder: 5g powder mixed with 100 ml of water to be taken orally three times a day before food Control Intervention1: ORAL REHYDRATION SOLUTION: 5g powder mixed with 100 ml of wa

Sponsors

Clinfound Clinical Research Services PvtLtd
Lead Sponsor
CareKeralam Limited
Collaborator

Eligibility

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
DIARRHOEA QUESTIONNAIRETimepoint: Day1,Day2,Day3,Day4

Secondary

MeasureTime frame
Adverse EventsTimepoint: Day1,Day2,Day3,Day4;STOOL MICROSCOPYTimepoint: Day1,Day4

Countries

India

Contacts

Public ContactSreejith Sreekumar

Susrusha Hospital

susrusharesearch@gmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026