Good Health Clinical Trial
Official title:
A Phase I Single Blind, Randomized, Placebo Controlled, Parallel Group Study to Investigate the Safety and Tolerability of SF2000SD in Healthy Male Volunteers
The purpose of this study is to assess the safety and tolerability of SF2000SD in adult male healthy volunteers
INTRODUCTION: Treatment and management of people suffering from HIV, AIDS and opportunistic
infections using conventional therapeutic interventions is beyond the reach of most
governments because of the cost of imported medicines. The WHO has approved the strategy and
promotion of the use of Traditional Medicine in Health Systems.
The primary health care places traditional medicines high on its list of priorities and
emphasizes their easy availability and use. There is however a need for scientific validation
of most potential medicinal plants available in many poor countries and research must focus
on the safety and efficacy of these traditional medicines to support their widespread usage.
This study intends to conduct a phase I clinical trial using the SF2000SD.
History of SF2000 use: The Sondashi Formula 2000, code named "SF2000" is a mixture of 4
plants. Patients suffering from HIV/AIDS have been using this traditional medicine for the
management of their illness.
JUSTIFICATION:
A more acceptable dosage form i.e. a spray dried extract (SF2000SD) has been developed based
on the SF2000 inventor's traditional preparation the commencement of a phase I clinical
safety study involving eligible adult male health individual volunteers is warranted.
Information will be collected to scientifically ascertain the safety of SF2000 in these
volunteers paving the way for a phase II clinical study to be conducted after phase I.
METHODS:
Study design: The study will be a longitudinal clinical trial of adult healthy male
volunteers taking SF2000SD or placebo under directly observed therapy (DOT). The study
participants will be randomized to each treatment arm as they are being enrolled into the
study. Each treatment arm/group A, B and C will have fifteen (15) study participants, total
45. Apart from the PI the other investigators will be blinded to the participants' treatment
arms. The study participants will also be blinded to the treatment arms and their contents.
Study site: The study shall be undertaken at the Tropical Diseases Research Centre, Ndola.
Study personnel The following personnel will be available.
1. Project administrator
2. Social scientists
3. Research nurses
4. Lab assistants
5. Clinical Officer
6. Medical doctor
7. Pharmacist
8. Specimen Courier staff
Recruitment: Sensitization and awareness posters, volunteer brochures and flyers, direct
mailing and presentations will be given to the targeted community. Volunteers will receive
further briefing from the Principal Investigator (PI) or Co-Principal Investigator. The
briefing will be followed by an opportunity for questions from the volunteers. Potential
study participants will be screened for eligibility to participate in the study. All study
participants will receive counseling pertaining to their intent to participate in the study
from qualified counselors of the research team. Written informed consent which will be
validated by the PI or his designee will be obtained from all participants. Forty five (45)
healthy males will be recruited into the study.
Method of assigning study participants to treatment arm/group: The blocked randomization
method will be used to allocate the participants to the treatment. Selection of participants
to each treatment will be based on the rank of 45 randomly generated numbers of sizes between
0 and 1, generated for each sequential participant. Accordingly, participants in blocks of 3
will be ranked according to the random number.
In each block the participants with the highest rank will be allocated to treatment A, the
ones with the second highest will be allocated to treatment B, and the ones with the third
highest will be allocated to treatment C. A randomization list with participants
Identification (ID) numbers will be generated by the statistician and will be kept by the PI.
Treatment packs will bear participant ID numbers. Only the PI will know the treatment
allocations.
Drug administration: Participants will start taking the dose orally in their respective
treatment arms when recruitment for the study is complete. In order to ensure that the study
drug is taken, a Directly Observed Treatment (DOT) approach will be used. The study drug will
be administered twice daily between 06.00hrs - 09.00hrs and 17.00hrs - 20.00hrs for six
weeks. All administrations will be recorded on the dosing sheet and signed by the person
administering the treatment and Co-PI or Medical Doctor.
Data Collection: The participants will be required to report any adverse events immediately.
At each visit, the participants will also be interviewed on any adverse events since the
previous visit. Furthermore, participants will be required to keep a dairy of adverse events
for the duration of the study.
The laboratory tests will mainly be carried out at the Tropical Diseases Research Centre
(Ndola), and Ndola Central Hospital (Ndola).
The frequency and data collection points at screening, baseline and weeks 1, 3, 6 and 8.
Screening: Week -2 to -1
- Demographic Data and counselling: Demographic data will be recorded and counselling
session on HIV testing will be initiated.
- Informed consent: After an in-depth interview, with one study nurse the participant will
be asked to document her consent by signing an informed consent. The signed informed
consent must be obtained before any tests or evaluations related to the study are
carried out.
- Vital Signs: axillary temperature, blood pressure, respiratory rate and pulse, height
and weight will be measured.
- Medical history Physical and Clinical Examination: The medical history of the potential
participant and general physical examination will be performed.
- Laboratory Tests: HIV, HBV and HCV testing, malaria microscopy, Urinalysis - dipstix,
Blood hemoglobin, full blood count and differential, liver and renal function tests will
be performed.
- Discharge: Participant will be discharged and will be asked to report one day after at
06:00 hours for the assessment of the eligibility criteria.
Enrolment and study drug administration visit: Week 0
- Vital signs Vital signs will be measured
- Enrolment The Co-PI or the Medical Doctor will assess the eligibility criteria. Eligible
participants should have a Karnofsky score of 100% (Appendix XI) The eligible candidate
will receive an ID number and will be sent to the study nurse for medication.
Non-eligible potential participant will be referred accordingly.
- Medication Study drug will be administered using DOT strategy
- Adverse event and discharge Any adverse event will be recorded, for the details see
appendix Discharge after thirty minutes form the time the drug was administered Follow
up period: Week 1 to 6
- Adverse Events Report All adverse events will be recorded. Use appendix IV to check for
any adverse effects
- Concomitant Medications Any medications taken by the study including traditional
medicine subject will be recorded.
- Vital Signs Vital signs will be measured
- Physical and Clinical Examination A general physical examination and a clinical
examination will be performed
- Laboratory tests: HIV, HBV and HCV testing, malaria microscopy, Urinalysis - dipstix,
Blood hemoglobin, full blood count and differential, liver and renal function tests will
be performed.
- Treatment Study drug will be administered; information on medication will be documented
including information on any concomitant medication given for the management of adverse
events.
- Unscheduled visits throughout follow up during these visits, the same procedures will be
applied. Any laboratory study specific or any other measurements can be performed,
according to the physician's clinical judgement.
Data Entry: The data generated will be entered and analyzed by STATA computer software.
Statistical Analysis: Null Hypothesis set p-values The SF2000SD herbal preparation is not
safe for human consumption P-value = 0.05.
The adverse events will be classified into three to five categories (Adverse events
categories against the three "treatments"). Proportions will be compared using the Chi-square
test. If the expected frequencies will be less than 5%, then the Fisher's t test will be
used. The students' t test will be used to compare the means. The level of statistical
significance will be set at 5%.
The clinical findings will also be classified into three to five categories and an exact
chi-square test will be done.
If the null hypothesis (no association between occurrence of adverse events or physical
examination findings for exact chi-square test and no difference in the changes for analysis
of variance test) in the exact Chi-square test or the analysis of variance test is rejected
then multiple comparison tests and stratified analysis will be done to compare the placebo
against the other treatments.
Conduct interim analysis at week 3 of study starting from baseline (baseline to be all at the
same time for all 45 participants if possible - must be included in randomization).
QUALITY CONTROL: The Investigators will review the consent and screening processes with all
study stuff prior to commencement of the study to ensure that a standardized approach is
followed during the study. In addition, the Investigators will frequently conduct performance
assessments of the study support staff to ensure smooth collection of reliable data and
review participants' concerns during the study. In addition the study monitor will visit at
initiation, during the conduct of the study and at closure to verify if the study is being
conducted in compliance with, Protocol/amendment(s), with Good Clinical Practices, Standard
Operating Procedures (SOPs) and applicable regulatory requirements.
PROCEDURES TO HANDLE ADVERSE EVENTS: At admission for each treatment period study
participants will be instructed to report any changes in normal health that they experience
to the Principal Investigator or Co-Principal Investigator. AEs will also be elicited by
indirect questioning at regular intervals, usually at the time of measurement of vital signs,
with such questions as "How do you feel today? or "Is anything bothering you?" No study
participant shall be permitted any medication during the study except as permitted by the
study medical doctor.
All AEs or symptoms will be recorded in the CRF. Any SAE will be reported to the Principal
Investigator/Co- Principal Investigator, within 48 hours (0977 655096 or 0966 263271), who in
turn will report them to the Ethics Committee and DSMB. On the basis of the occurrence and
severity of AEs, coupled with results of any other observations, the Principal Investigator
or Co-Principal Investigator, at his discretion and in consultation with the DSMB, may decide
to withdraw a study participant or prematurely end the study for reasons of clinical safety.
The time of such termination will be recorded and palliative treatment will be instituted as
needed.
TRIAL STOPPING RULES: The DSMB has the right to stop the trial based on the following rules:
- The occurrence of any major life threatening adverse event may result in the trial being
abandoned immediately at the discretion of the DSMB. The investigators together with the
DSMB may agree to stop the study should a certain number of participants experience SAE.
- An occurrence of a SAE directly attributed to SF2000SD.
- If any number of participants have abnormal laboratory results or other AEs over Grade 3
as per the exclusion criteria, then this would warrant for the exceptional meeting of
the DSMB to determine whether the trial should be stopped.
REASONS FOR NOT COMPLETING THE STUDY: Participants may not complete the study for medical or
non-medical reasons PROJECT MANGEMENT: The project will be managed by four investigators: PI,
Co-PI (MD), Biostatistician and Social Scientist.
DATA MONITORING: Data Safety Monitoring Board (DSMB) will be responsible to monitor the
progression of the study and analyzing the data generated.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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