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

Dengue Clinical Trial

— CF2013  

Official title:

Pharmacological Effect of Carica Folia Mother Tincture in Healthy Individual's Blood Parameter.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02016027
• Other study ID #: carica 2013
• Secondary ID: NCD
• Status: Enrolling by invitation
• Phase: Phase 1
• First received: November 21, 2013
• Last updated: December 14, 2013
• Start date: September 2013
• Est. completion date: December 2013

Study information

• Verified date: December 2013
• Source: Fr Muller Homoeopathic Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 25 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dengue

Intervention

Drug:
• Carica folia

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fr Muller Homoeopathic Medical College

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in platelet count		3 days	No
Secondary	Increase in Red Blood Cell count		3 days	No