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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 

 
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