NCT02941159

Brief Summary

The purpose of this study is to assess the safety and tolerability of SF2000SD in adult male healthy volunteers

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
43

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 8, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 21, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

1.2 years

First QC Date

October 8, 2016

Last Update Submit

November 16, 2017

Conditions

Good Health

Outcome Measures

Primary Outcomes (3)

  • Proportion of study participants with clinical adverse events such as diarrhea, vomiting, changes in vital signs etc. associated with the test product

    56 days

  • Proportion of study participants with changes in laboratory liver and renal values after administration of test product. These will include ALT, AST, ALP, Total biluribin, Glucose, Urea and Creatinine

    56 days

  • Proportion of study participants with changes in blood hematological values after administration of test product. This will involve Full Blood Count (FBC) including differential for white blood cells

    56 days

Study Arms (2)

SF2000SD

ACTIVE COMPARATOR

The test product is a Sondashi Formula Spray dried extract (SF2000SD). It is derived from spray drying with water the Sondashi Formula (SF2000), which is a mixture of mixture of 4 plants. SF2000SD is packaged into capsules of 500mg and six capsules are taken twice, daily for 42 days. This drug has anti-HIV properties but in this study we are just looking at safety issues.

Biological: SF2000SD

Placebo

PLACEBO COMPARATOR

The placebo arm is composed of capsule containing 500mg of inactive ingredient (Microcrystalline Cellulose PH102 -240mg; Starch - 10mg; Magnesium Stearate -10mg; and Maltodextrin Unidry 20 - 240mg).

Biological: Placebo

Interventions

SF2000SDBIOLOGICAL

This is an intergrase inhibitor

SF2000SD
PlaceboBIOLOGICAL
Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • To be eligible to participate in study, the participant should be;
  • Male aged 18 to 45 years.
  • Available in Ndola during the 10 weeks study duration.
  • Able to provide proof of residence.
  • Able to complete Consent Form
  • In good health as determined by the combination of medical history, physical examination, and clinical judgment and laboratory results following TDRC normal ranges. Urine dipstick for protein and blood should be negative or trace. If either is ≥1+, complete urinalysis will be obtained (UA). If microscopic UA confirms hematuria or proteinuria ≥ 1+, the volunteer is ineligible.
  • Serologically negative for HIV, HBV and HCV infection.

You may not qualify if:

  • Female
  • A history related to TB
  • Any of the following chronic illnesses: diabetes, asthma, hypertension, skin conditions.
  • On herbal medicine and/ or traditional medicines or immune boosting treatments
  • Received an investigational drug or herbal medicine not less than 2 months by the time of administration of the study dose
  • excessive alcohol consumption/alcohol abuse
  • Smokes
  • HIV and/or HBV and/or HCV positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tropical Diseases Resaerch Centre

Ndola, Copperbelt, 71769, Zambia

RECRUITING

Related Publications (3)

  • Holliday I. Traditional medicines in modern societies: an exploration of integrationist options through East Asian experience. J Med Philos. 2003 Jun;28(3):373-89. doi: 10.1076/jmep.28.3.373.14587.

    PMID: 12815539BACKGROUND

  • Arimori S, Nozaki H, Morita K, Arimori K. Case report: the effect of a Chinese herbal medicine, BG-104 in two HIV positive hemophiliacs. Biotherapy. 1993;7(1):55-7. doi: 10.1007/BF01878154.

    PMID: 7915126BACKGROUND

  • Timmermans K. Intellectual property rights and traditional medicine: policy dilemmas at the interface. Soc Sci Med. 2003 Aug;57(4):745-56. doi: 10.1016/s0277-9536(02)00425-2.

    PMID: 12821021BACKGROUND

Study Officials

  • Ray Handema, PhD

    Tropical Diseases Research Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Modest Mulenga, MD; PhD

CONTACT

+260-212-620737mulengam@tdrc.org.zm

Shepherd Khondowe, MPH

CONTACT

+260-212-620737khondowes@tdrc.org.zm

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2016

First Posted

October 21, 2016

Study Start

September 1, 2016

Primary Completion

November 1, 2017

Study Completion

February 1, 2018

Last Updated

November 17, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will share

Available IPD Datasets

Study Protocol Access

Locations

ZA(1)