DenguePhase 1CF2013NCT02016027
Pharmacological Effect of Carica Papaya Leaves Mother Tincture in Healthy Individuals Blood Parameter
A Phase 1 study testing Carica folia in people with Dengue, run by Fr Muller Homoeopathic Medical College.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue
- What is being tested?
- Carica folia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy individuals
- Age group- 18yrs to 25yrs
- both sexes
- free from any type of medicinal agent at least 15 days before commence the intervention.
Who cannot join
- 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.
About this study
Official title: Pharmacological Effect of Carica Folia Mother Tincture in Healthy Individual's Blood Parameter.
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.
Read more
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.
- Conditions
- Dengue
- Being tested
- Carica folia
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carica foliaDrug
| Study group | Role | What they receive |
|---|---|---|
| Carica folia Arm | Experimental | Not described Receives: Drug: Carica folia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in platelet count
Measured: 3 days
Secondary outcomes (1)
Increase in Red Blood Cell count
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DengueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fr Muller Homoeopathic Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Nimai Chandra Dhole, Fr Muller Homoeopathic Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016027
- Sponsor's protocol ID
- carica 2013
- Other IDs
- NCD
- Acronym
- CF2013
- Status last verified
- Dec 2013
- First submitted
- 21 Nov 2013
- Last updated
- 19 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological Effect of Carica Folia Mother Tincture in Healthy Individual's Blood Parameter.
- ClinicalTrials.gov ID
- NCT02016027
- Acronym / sponsor ID
- CF2013 / carica 2013
- Conditions
- Dengue
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fr Muller Homoeopathic Medical CollegeUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 19 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carica folia Arm | Experimental | Drug: Carica folia |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy individuals
- Age group- 18yrs to 25yrs
- both sexes
- free from any type of medicinal agent at least 15 days before commence the intervention.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carica folia | Drug | Carica folia Arm |
Primary outcome
Increase in platelet count
Time frame: 3 days
1 secondary outcome
Increase in Red Blood Cell count
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Carica folia in people with Dengue, run by Fr Muller Homoeopathic Medical College.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in platelet count (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2013.