Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201504001033387 Date of Approval: 13/02/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title efficacy of adjunctive moxibustion in the treatment of Tuberculosis
Official scientific title efficacy of adjunctive moxibustion in the treatment of Tuberculosis
Brief summary describing the background and objectives of the trial There is old East Asian literature suggesting that moxibustion was used to treat TB We did an open-label RCT of 180 Pulmonary TB patients; 90 on TB treatment alone and 90 on both TB and moxibustion Using modern TBdiagnosis and follow-up resources. we are to follow the patients from diagnosis to end of treatment We do sputum ZN stains, Chest X-ray, WBC counts, CD4 and CD8 count as well as clinical examination as part of diagnosis and follow up we intend to compare rates of sputum conversion (cure), clinical improvement, and CD4/CD8 improvement between the two arms of the study. This will show whether adding moxa to TB treatment improves chances of cure, improves immunity (like it was suggested in old literature), or helps patients live a better life while on TB treatment.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Tuberculosis
Purpose of the trial Treatment: Drugs
Anticipated trial start date 20/08/2012
Actual trial start date 20/08/2012
Anticipated date of last follow up 30/11/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 180
Actual target sample size (number of participants) 180
Recruitment status Recruiting
Publication URL www.moxafrica.org
Secondary Ids Issuing authority/Trial register
HS 1227 Uganda National Council for Science and Technology
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised simple randomisation using a randomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used) Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group moxibustion daily moxa (minimum 3 applications on a leg) 8 months moxibustion: a piece of moxa (size of rice grain) is put on the leg and then ignited until the patient just feels the heat from the moxa 90
Control Group TB Treatment TB treatment only 8 months Patients takes only pills of HRZE for months and 6months of HE 90 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Diagnosis of TB was by sputum smear -If Patient has been on TB treatment; it is for not more than 2 weeks -Patient should consent to join the study if he/she is to join it. -Patient should have an attendant who may help him/her with the treatment. -Patient is under the age of 18 years -Patient who were judged to be unable to understand the instructions (of what they are to do while in the study e.g. how to use moxa) -Patients intending to leave/change treatment center before their TB treatment duration ends -Patients who are unable to come on all follow up visits -History of Allergy to moxa/moxibustion -Diabetic patients were excluded -pregnant women -Coexistance of a Type of TB, or any other illnesses that require the participants to take steroids in addition to TB medicine -If TB was not diagnosed using sputum smears. 18 Year(s) 80 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 01/08/2012 Makerere University College of Health Science: School of Biomedical Sciences Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Makerere College of Health Science. P.O.BOX 7072 kampala 256 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome sputum conversion rates ( from positive to negative) -2 months (8 weeks) after starting TB treatment
Secondary Outcome sputum conversion rates ( from positive to negative) at 1 months (4 WEEKS) after starting TB treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kiswa Health Center II Bugolobi Opposite Shell petrol station Kampala 256 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Moxafrica 103 Chestnut Road, Oldbury Oldbury B68 0AY United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Moxafrica 103 Chestnut Road, Oldbury Oldbury B68 0AY United Kingdom Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Makerere University College of Health Sciences Makerere University, University Road kampala 256 Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator hood ibanda hibanda@gmail.com 256712701108 Makerere University
City Postal code Country Position/Affiliation
kampala 256 Uganda Teaching Assistant Department of pharmacology and therapeutics
Role Name Email Phone Street address
Public Enquiries Merlin Young MrlnYoung@aol.com (0)121 421 3480
City Postal code Country Position/Affiliation
Role Name Email Phone Street address
Scientific Enquiries Paul waako paulwaako@yahoo.com +256772468458 Makerere University
City Postal code Country Position/Affiliation
kampala 256 Uganda Principal Investigator, Head of Department of pharmacology, to mention but a few
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information