| CTRI Number |
CTRI/2012/10/003063 [Registered on: 16/10/2012] Trial Registered Retrospectively |
| Last Modified On: |
12/10/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Ginger caplets in Post operative nausea and vomiting |
|
Scientific Title of Study
|
A Double Blind, placebo controlled, Clinical study to evaluate the efficacy and safety of Ginger caplets in Post operative nausea and vomiting |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HDC/RD/PP/2010/121 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prakash G Venkat |
| Designation |
Professor at osmania medical College and consultant Surgeon at S.V.pooja Hospital |
| Affiliation |
S.V.Pooja Hospital |
| Address |
S.V.Pooja hospital, Hyderanagar,
Hyderabad.
Hyderabad
ANDHRA PRADESH
500072
India |
| Phone |
09949028879 |
| Fax |
|
| Email |
gvprakash@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prakash G Venkat |
| Designation |
Professor at osmania medical College and consultant Surgeon at S.V.pooja Hospital |
| Affiliation |
S.V.Pooja Hospital |
| Address |
S.V.Pooja hospital, Hyderanagar,
Hyderabad.
ANDHRA PRADESH
500072
India |
| Phone |
09949028879 |
| Fax |
|
| Email |
gvprakash@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prakash G Venkat |
| Designation |
Professor at osmania medical College and consultant Surgeon at S.V.pooja Hospital |
| Affiliation |
S.V.Pooja Hospital |
| Address |
S.V.Pooja hospital, Hyderanagar,
Hyderabad.
ANDHRA PRADESH
500072
India |
| Phone |
09949028879 |
| Fax |
|
| Email |
gvprakash@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| The Himalaya Drug Company |
|
|
Primary Sponsor
|
| Name |
The Himalaya Drug Company |
| Address |
The himalaya Drug company, Research and Development, Makali, Bangalore-562123
Tel: 08022169999 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prakash G Venkat |
Dr Prakash G Venkat |
Consultant surgeon, Department of surgery, S.V.Pooja Hospital, Hyderanagar,
Hyderabad
Hyderabad
ANDHRA PRADESH |
09949028879
-
gvprakash@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Protection Plus Institutional review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Post operative nausea and vomiting, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GINGER CAPLET |
Ginger caplets, 1 caplet twice daily for 10 days. |
| Comparator Agent |
Similar looking Placebo caplet |
1 caplet to be taken twice daily over the period of 10 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
• 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.
|
|
| ExclusionCriteria |
| Details |
• 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
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| To assess the safety profile of Ginger caplets and overall compliance |
Assessment is done at entry day 3 day 6 and day 10 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/10/2012 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Publication rights are with the sponsor. However the investigator can get it published after a written approval from the sponsor after the completion of the study. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Only
subjects who meet the subject selection section, have signed an informed
consent form and have an updated medical history on file with the investigator
will 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.
Subjective
and objective evaluation will be done. Assessment
will be done on entry, at the end of 3rd day, 6th day, 10
th day. Adverse effects as volunteered by the patients will be noted in the
CRFs. Information on each patient will be collected from their history,
General physical examination, systemic examination and laboratory investigations, and will be recorded on the
Case Report Form.
|