A Double Blind, placebo controlled, Clinical study to evaluate the efficacy and safety of Ginger caplets in Post operative nausea and vomiting
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- The Himalaya Drug Company
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- symptomatic relief from clinical symptoms of post operative nausea and vomiting
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Random Number Table
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •â€¢Patients who are posted for abdominal surgery, hernia, orthopedic and gynecological surgeries and also those patients presenting with Post operative nausea & vomiting.
- •â€¢Patients willing to sign informed consent.
Exclusion Criteria
- •â€¢Patients with severe vomiting related to CNS or severe gastrointestinal disorders.
- •â€¢Any evidence or history of hypersensitivity to herbal medicines.
- •â€¢Not willing to sign the informed consent or abide by the study procedure.
- •â€¢Pregnant or lactating women.
Outcomes
Primary Outcomes
symptomatic relief from clinical symptoms of post operative nausea and vomiting
Time Frame: Assessment is done at entry day 3 day 6 and day 10
Secondary Outcomes
- To assess the safety profile of Ginger caplets and overall compliance(Assessment is done at entry day 3 day 6 and day 10)