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

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ClinicalTrials.gov Identifier: NCT02016027
Recruitment Status : Unknown
Verified December 2013 by Dr Nimai Chandra Dhole, Fr Muller Homoeopathic Medical College.
Recruitment status was:  Enrolling by invitation
First Posted : December 19, 2013
Last Update Posted : December 19, 2013
Sponsor:
Information provided by (Responsible Party):

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.


Condition or disease Intervention/treatment Phase
Dengue Drug: Carica folia Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacological Effect of Carica Folia Mother Tincture in Healthy Individual's Blood Parameter.
Study Start Date : September 2013
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Carica folia Arm Drug: Carica folia


Outcome Measures

Primary Outcome Measures :
  1. Increase in platelet count [ Time Frame: 3 days ]

Secondary Outcome Measures :
  1. Increase in Red Blood Cell count [ Time Frame: 3 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
More Information

Responsible Party: Dr Nimai Chandra Dhole, Principal Investigator, Fr Muller Homoeopathic Medical College
ClinicalTrials.gov Identifier: NCT02016027     History of Changes
Other Study ID Numbers: carica 2013
NCD
First Posted: December 19, 2013    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: December 2013