Ginger caplets in Post operative nausea and vomiting

Phase 3

Recruiting

• Conditions: Post operative nausea and vomiting

• Registration Number: CTRI/2012/10/003063
• Lead Sponsor: The Himalaya Drug Company

Brief Summary

Onlysubjects who meet the subject selection section, have signed an informedconsent form and have an updated medical history on file with the investigatorwill be entered into the study. As per the random number table the subject will receive either Ginger caplet or placebo at a dose of 1 caplet twice daily for the period of 10 days.

Subjectiveand objective evaluation will be done. Assessmentwill be done on entry, at the end of 3rd day, 6th day, 10th day. Adverse effects as volunteered by the patients will be noted in theCRFs. Information on each patient will be collected from their history,General physical examination, systemic examination and laboratory investigations, and will be recorded on theCase Report Form.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-15
• Last Update Posted: 2012-12-10

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• •Patients who are posted for abdominal surgery, hernia, orthopedic and gynecological surgeries and also those patients presenting with Post operative nausea & vomiting.
• •Patients willing to sign informed consent.

Exclusion Criteria

• •Patients with severe vomiting related to CNS or severe gastrointestinal disorders.
• •Any evidence or history of hypersensitivity to herbal medicines.
• •Not willing to sign the informed consent or abide by the study procedure.
• •Pregnant or lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
symptomatic relief from clinical symptoms of post operative nausea and vomiting	Assessment is done at entry day 3 day 6 and day 10

Secondary Outcome Measures

Name	Time	Method
To assess the safety profile of Ginger caplets and overall compliance	Assessment is done at entry day 3 day 6 and day 10

Trial Locations

Locations (1)

Dr Prakash G Venkat; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Dr Prakash G Venkat

🇮🇳Hyderabad, ANDHRA PRADESH, India

Dr Prakash G Venkat

Principal investigator

09949028879

gvprakash@rediffmail.com