Plain English Summary
Background and study aims
Amoebiasis is an infection of the gut caused by a parasite called Entamoeba histolytica, which is found in most tropical areas. Infections occur in both the intestine and (in people with symptoms) in the tissue of the intestine and/or liver. As a result, two different classes of drugs are needed to treat the infection, one for each location, such as metronidazole and diloxanide furoate. It is claimed that a herbal medicine (Endemali) treats both types of infection with very few side effects. The aim of this study is to find out which of the two treatments is better with respect to effectiveness and side effects in order to find an alternative treatment for E. histolytica, which is developing growing resistance against the traditional medicine.
Who can participate?
Patients aged 5 to 60 with amoebiasis
What does the study involve?
Participants are randomly allocated to one of two treatment groups. One group was treated with a combination of metronidazole and diloxanide furoate three times a day for 5 days. The other group was treated with Endemali four times a day for 10 days. During the course of treatment, participants are checked for the development of side effects or any other complications. At the end of the study participants are checked for the presence or absence of E. histolytica.
What are the possible benefits and risk of the participating?
This study could help patients in the future by providing an option of a drug which is more effective and has fewer side effects. Participants are provided with treatment and their investigations free of charge. Those for whom the treatment did not work are further investigated and provided with other treatment options without charge. There is a chance of developing side effects and the drugs may not work.
Where is study run from?
Hamdard University (Pakistan)
When is the study starting and how long is it expected to run for?
January to December 2008
Who is funding the study?
Hamdard University (Pakistan)
Who is the main contact?
1. Prof. Dr Muhammad Irfanullah Siddiqui (irfan7255@yahoo.com)
2. Prof. Dr Usman Ghani (ugk_2005@yahoo.com)
Trial website
Contact information
Type
Scientific
Primary contact
Prof Muhammad Irfanullah Siddiqui
ORCID ID
Contact details
House No A-4 ST-33
Sector 11-A near British Bakery
Karachi
75850
Pakistan
-
irfan7255@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
001
Study information
Scientific title
A randomized double blind study to find out whether there is any difference in the efficacy and side effects of Endemali® and a combination of diloxanide furoate and metronidazole
Acronym
Study hypothesis
There are two hypothesis simultaneously tested:
1. It is hypothesized that there is some difference between Endamali (a herbal medicine) and a combination of metronidazole and diloxanide furoate with respect to efficacy and side effects. (Two-tailed)
Null hypothesis: There is no difference in the efficacy of Endamali and a combination of metronidazole and diloxanide furoate with respect to efficacy.
2. It is hypothesized that there is some difference between Endamali (a herbal medicine) and a combination of metronidazole and diloxanide furoate with respect to side effects. (Two-tailed)
Null hypothesis: There is no difference in the efficacy of Endamali and a combination of metronidazole and diloxanide furoate with respect to side effects.
Ethics approval
Ethics Committee of Hamdard University, 16/01/2007, ref: CMHCMD/001/2007
Study design
Double-blind randomized parallel bi-centric study
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Amoebiasis
Intervention
To determine the sample size, we used α <0.05 and power of study as 90%. The effect size considered to be clinically significant, was a 0.15 difference between two groups based on a pilot study. Hypothesis test for two population proportion with two sided test was calculated with the help of WHO Manual. A total of 101 sample size was calculated for each group. The total 202 patients were divided into 21 blocks. The block technique used has already been described in the application sent to you, in which we used the block of 10 in order to have almost equal number of participants in both group. Out of the 10 sheet written for each block, five were marked "treatment group 1"(TR1) and rest as "treatment group 2" (TR2). Each eligible participant was invited to pick blindly one sheet out of 10 available. Once the five patients of one treatment group were complete, rest of the patients were allocated to the other group e.g. in one draw first patient picked TR1, second also picked TR1, 3rd picked TR2, 4th picked TR1 5th picked TR2, 6th picked TR2, 7th picked TR2, 8th picked TR1, 9th picked TR1 and then 10th was automatically allocated to TR2. Once a sheet was picked, after noting the group allocation, it was put back in the drawer to make it 10 again so that every patient has an equal probability of being allocated to any of the group.
Treatment group 1: combination of metronidazole + diloxanide furoate available in Pakistan with brand name "Entamizole DS". This tablet contains metronidazole 400mg + diloxanide furoate 500mg. Entamizole DS was given 3 times a day for 5 days.
Treatment group 2: Endemali®, a herbal product, available in 4gm sachet, containing Boswellia glabra 270.9 mg, Kaolinum ponderosum 255 mg, Ocimum pilosum 580 mg, Pistacia terbinthus 116.1 mg, Plantago ispagula 812.7 mg, Vateria indica 232.2mg sweeting agent q.s. Endemali® was given 4 times a day for 10 days.
Intervention type
Drug
Phase
Not Applicable
Drug names
Diloxanide furoate, metronidazole
Primary outcome measure
Efficacy at baseline and 5 days after stopping the treatment
Secondary outcome measures
1. Side effects
2. Association of age with efficacy
3. Association of sex with efficacy
4. Association of age with side effects
5. Association of sex with side effects
Measured at baseline and immediately after completion of course of treatment.
Overall trial start date
01/01/2008
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. All the confirmed cases of amoebiasis and between the ages of 5 and 60 years were invited to be included in the study
2. Willing to be assigned to any of the two treatment groups
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
202
Participant exclusion criteria
All those who had multiple problems
Recruitment start date
01/01/2008
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Pakistan
Trial participating centre
House No A-4 ST-33
Karachi
75850
Pakistan
Sponsor information
Organisation
Hamdard University (Pakistan)
Sponsor details
Madinat Al Hikmah
Muhammad Bin Qasim Avenue
Near Bund Murad
Gadap town
Karchi
74600
Pakistan
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Hamdard University (Pakistan)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list