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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Dr Nimai Chandra Dhole, Fr Muller Homoeopathic Medical College
ClinicalTrials.gov Identifier:
NCT02016027
First received: November 21, 2013
Last updated: December 14, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Dengue
Drug: Carica folia
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacological Effect of Carica Folia Mother Tincture in Healthy Individual's Blood Parameter.

Resource links provided by NLM:


Further study details as provided by Fr Muller Homoeopathic Medical College:

Primary Outcome Measures:
  • Increase in platelet count [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Increase in Red Blood Cell count [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carica folia Arm Drug: Carica folia

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: November 21, 2013
Last Updated: December 14, 2013
Health Authority: India: Institutional Review Board

ClinicalTrials.gov processed this record on September 30, 2014