NCT02016027

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_1

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2013

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 19, 2013

Completed
Last Updated

December 19, 2013

Status Verified

December 1, 2013

Enrollment Period

3 months

First QC Date

November 21, 2013

Last Update Submit

December 14, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Increase in platelet count

    3 days

Secondary Outcomes (1)

  • Increase in Red Blood Cell count

    3 days

Study Arms (1)

Carica folia Arm

EXPERIMENTAL
Drug: Carica folia

Interventions

Carica folia Arm

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy individuals
  • Age group- 18yrs to 25yrs
  • both sexes
  • free from any type of medicinal agent at least 15 days before commence the intervention.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 21, 2013

First Posted

December 19, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 19, 2013

Record last verified: 2013-12