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Pharmacological Effect of Carica Papaya Leaves Mother Tincture in Healthy Individuals Blood Parameter (CF2013)

Primary Purpose

Dengue

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Carica folia
Sponsored by
Fr Muller Homoeopathic Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dengue

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Carica folia Arm

    Arm Description

    Outcomes

    Primary Outcome Measures

    Increase in platelet count

    Secondary Outcome Measures

    Increase in Red Blood Cell count

    Full Information

    First Posted
    November 21, 2013
    Last Updated
    December 14, 2013
    Sponsor
    Fr Muller Homoeopathic Medical College
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02016027
    Brief Title
    Pharmacological Effect of Carica Papaya Leaves Mother Tincture in Healthy Individuals Blood Parameter
    Acronym
    CF2013
    Official Title
    Pharmacological Effect of Carica Folia Mother Tincture in Healthy Individual's Blood Parameter.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2013
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2013 (undefined)
    Primary Completion Date
    December 2013 (Anticipated)
    Study Completion Date
    December 2013 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fr Muller Homoeopathic Medical College

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dengue

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Carica folia Arm
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Carica folia
    Primary Outcome Measure Information:
    Title
    Increase in platelet count
    Time Frame
    3 days
    Secondary Outcome Measure Information:
    Title
    Increase in Red Blood Cell count
    Time Frame
    3 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

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    Pharmacological Effect of Carica Papaya Leaves Mother Tincture in Healthy Individuals Blood Parameter

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