- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02016027
Pharmacological Effect of Carica Papaya Leaves Mother Tincture in Healthy Individuals Blood Parameter (CF2013)
Pharmacological Effect of Carica Folia Mother Tincture in Healthy Individual's Blood Parameter.
AIMS & OBJECTIVES To evaluate the effectiveness of administering of Carica folia mother tincture to healthy individual's Platelet count.
Sample Details:- Students, Doctors and non-teaching staffs of Father Muller Homoeopathic Medical College are taken up for the study. A minimum of 60 persons will be selected and will be divided into two groups, Control & Experiment by lottery method.
Voluntary participation in the study is expected. 30 persons in each group. One group will receive Carica folia mother tincture and other group will receive placebo.
Complete Blood count including platelet count will be measured for all 60 subjects before commencing the study.
The drug namely Carica Folia mother tincture will be procured from Father Muller Homoeopathic Pharmaceutical Division which compiles with the standards of Homoeopathic Pharmacopeia of India.
Daily dosage -30 drops of Carica Folia mother tincture in 30 ml of distilled water morning and night for 3days.
On 4th day complete blood count including platelet count will be estimated for all 60 subjects.
Research Methodology and Statistics:
Pre &Post with Control Design is done. Data from the sample is collected and is subjected to Paired 't' test and unpaired 't' test.
HYPOTHESIS:-
Null hypothesis:
No significant changes in complete blood count and platelet count before and after the intervention.
Alternate hypothesis:
There is significant variation in complete blood count and platelet count before and the intervention.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- healthy individuals
- Age group- 18yrs to 25yrs
- both sexes
- free from any type of medicinal agent at least 15 days before commence the intervention.
Exclusion Criteria:
- person suffering from any illnesses
- age group below 18yrs and above 25yrs.
- person taking any medicinal agents, vitamins or any kinds of supplements will not be considered as subject.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Carica folia Arm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Increase in platelet count
Time Frame: 3 days
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Increase in Red Blood Cell count
Time Frame: 3 days
|
3 days
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- carica 2013
- NCD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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