CTRI Number |
CTRI/2014/05/004610 [Registered on: 20/05/2014] Trial Registered Retrospectively |
Last Modified On: |
28/03/2014 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda Preventive |
Study Design |
Other |
Public Title of Study
|
Study on traditional plant-based remedy for prevention of malaria: A community based study
|
Scientific Title of Study
|
The study on Traditional Plant Based Remedy for Prevention of Malaria: A Community Based Study |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
05 TPPM-K |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Prakash BN |
Designation |
Senior Research Officer |
Affiliation |
Foundation for Revitalisation of Local Health Traditions |
Address |
Foundation for Revitalisation of Local Health Traditions,Institute of Ayurveda and Integrative Medicine, No. 74/2, Jarakabande Kaval, Attur PO, Via Yelahanka,
Bangalore, Karnataka, India
Bangalore KARNATAKA 560106 India |
Phone |
9448088122 |
Fax |
08028567926 |
Email |
bn.prakash@frlht.org |
|
Details of Contact Person Scientific Query
|
Name |
Dr Padma Venkat |
Designation |
Joint Director |
Affiliation |
Foundation for Revitalisation of Local Health Traditions |
Address |
Foundation for Revitalisation of Local Health Traditions,Institute of Ayurveda and Integrative Medicine, No. 74/2, Jarakabande Kaval, Attur PO, Via Yelahanka,
Bangalore, Karnataka, India
Bangalore KARNATAKA 560106 India |
Phone |
9482582825 |
Fax |
08028567926 |
Email |
padma.venkat@frlht.org |
|
Details of Contact Person Public Query
|
Name |
Dr Prakash BN |
Designation |
Senior Research Officer |
Affiliation |
Foundation for Revitalisation of Local Health Traditions |
Address |
Foundation for Revitalisation of Local Health Traditions,Institute of Ayurveda and Integrative Medicine, No. 74/2, Jarakabande Kaval, Attur PO, Via Yelahanka,
Bangalore, Karnataka, India
Bangalore KARNATAKA 560106 India |
Phone |
9448088122 |
Fax |
08028567926 |
Email |
bn.prakash@frlht.org |
|
Source of Monetary or Material Support
|
ETC/COMPAS
P.O. Box 64
Kastanjelaan 5
3830 AB Leusden
The Netherlands |
Local NGO - THREAD :Team for Human Research Education & Action for Development, At/Po: Kakiriguma, Via Laxmipur, Dist: Koraput, Odisha, India |
|
Primary Sponsor
|
Name |
ETC COMPAS |
Address |
P.O. Box 64
Kastanjelaan 5
3830 AB Leusden
The Netherlands |
Type of Sponsor |
Other [Network] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Prakash BN |
Kakiriguma |
Tunpar and Kellar villages,Kakiriguma, Laxmipur block, Koraput district Koraput ORISSA |
9448088122
bn.prakash@frlht.org |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
FRLHT-Institutional Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
To prevent malaria in malaria-endemic villages |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
NIL |
Intervention was not given to this group. |
Intervention |
Poly-herbal decoction |
A poly-herbal decoction consists of five medicinal plants namely Azadirachta indica, Andrographis paniculata, Nyctanthes arbor-tri-stis, Piper nigrum, Zingiber officinale which are traditionally used as malaria preventive remedy.45 ml of freshly prepared decoction was orally administered twice a week in the evening hours (4PM to 7PM for 14 weeks. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
•Persons who are interested (voluntary) to take remedy for a prescribed period by participating in the study by providing written informed consent
•Persons who are healthy based on medical examination
|
|
ExclusionCriteria |
Details |
•Persons who are suffering from malaria or fever due to any other reason.
•Pregnant women, lactating women, children
•Persons who have co-morbid major medical illness like any infectious and communicable diseases
•Persons who are on any other long term medication (anti-diabetic/ anti-hypertensive/anti tubercular etc.)
•Persons on presumptive treatment for malaria.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Other |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Reduction in the malaria incidence among healthy volunteers who participate in the intervention group. |
5 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Improvement of general health in volunteers and non prevalence of any adverse effects during the study. |
5 months |
|
Target Sample Size
|
Total Sample Size="500" Sample Size from India="500"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
04/05/2009 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="8" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
None Yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Malaria remains a major public health problem in India. 220 million human get infected and over 700,000 deaths reports annually [1]. India contributes over one fifth (22.6%) of clinical episodes of Plasmodium falciparum and 42% of episodes of Plasmodium vivax globally [2,3] and around 200,000 persons die annually of malaria [4]. The situation of malaria is aggravated by an increased prevalence of drug-resistant P. falciparum, which poses a threat not only to those living in endemic areas, but also to the millions of non-immune travellers who visit endemic areas [6]. There is a need for safe and effective new drugs for both treatment and prevention of malaria [7]. As in almost all tropical endemic countries, malaria in India affects particularly people living in rural, remote areas, where most often affordable modern drugs are not available and where poor health care infrastructure cannot assure prompt and appropriate treatment. Thus, a majority of the population still relies on the use of traditional herbal medicines for the management of malaria. A recent ethnobotanical survey in Odisha, India, revealed the rich repertoire of traditional herbal remedies used for malaria prevention [8]. One polyherbal remedy (five plants parts) was selected for pilot field investigation, as it is widely used by many traditional healers to provide protection (preventive) specifically against malaria during the transmission season. The five plants used in this polyherbal remedy are commonly available in the local areas and are affordable to the population of malaria-endemic areas. As an exploratory, this pilot study was undertaken to evaluate the malaria preventive efficacy of polyherbal remedy in healthy volunteers. As these plants are mentioned in Ayurvedic classical texts for similar health condition (fever) and this remedy is already in use by many tribal communities of Odisha, we hypothesised that this remedy has an effect in reducing malaria incidences.
This study was initiated on May, 2009 and completed by December, 2009. This is a retrospective registration of the field, pilot study conducted to evaluate malaria preventive potential of polyherbal remedy in human healthy volunteers. This study was approved by the institutional ethics committee as per the norms and written informed consent was obtained from all the volunteers.
References: 1. WHO (2010): World malaria report 2010. 2. Hay SI, Okiro EA, Gething PW, Patil AP, Tatem AJ, et al. (2010) Estimating the global clinical burden of Plasmodium falciparum malaria in 2007. PLoS Med 7: e1000290. 3. Guerra CA, Howes RE, Patil AP, Gething PW, Van Boeckel TP, et al. (2010) The international limits and population at risk of Plasmodium vivax transmission in 2009. PLoS Negl Trop Dis 4: e774. 4. Dhingra N, Jha P, Sharma VP, Cohen AA, Jotkar RM, et al. (2010) Adult and child malaria mortality in India: a nationally representative mortality survey. Lancet 376: 1768-1774. 5. WHO (2009). World malaria report 2009.
6. Lobel HO, Campbell CC, Pappaioanou M, Huong AY (1987) Use of prophylaxis for malaria by American travelers to Africa and Haiti. JAMA 257: 2626-2627. 7. Olliaro P, Cattani J, Wirth D (1996) Malaria, the submerged disease. JAMA 275: 230-233. 8. Nagendrappa PB, Naik MP, Payyappallimana U (2013) Ethnobotanical survey of malaria prophylactic remedies in Odisha, India. J Ethnopharmacol 146: 768-772. |