NCT03366922

Evaluation of Artemisia Annua and Moringa

Completed NA Last updated 20 November 2020

What this trial tests

NA trial testing Artemisia Annua, Moringa oleifera in HIV Infections in 250 participants. Completed in 10 August 2020.

Timeline

10 December 2017

Primary endpoint
10 August 2020

10 August 2020

Quick facts

Lead sponsor	Mbarara University of Science and Technology
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	250
Start date	10 December 2017
Primary completion	10 August 2020
Estimated completion	10 August 2020
Sites	1 location across Uganda

Drugs / interventions tested

• Artemisia Annua, Moringa oleifera

Conditions studied

• HIV Infections — all drugs for HIV Infections →

Sponsor

Mbarara University of Science and Technology

Who can join

18 and older, any sex, with HIV Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Introduction Artemisia annua L is a medicinal plant traditionally used for treatment of malaria and other diseases in China. The extract of leaves of the plant has been demonstrated in-vitro to have potent anti HIV effects and in vivo to improve levels of lymphocytes in laboratory animals. Effect on lymphocyte stimulation has also been observed in non HIV persons taking the leaves of the plant as a tea for malaria prophylaxis in Uganda.

Objective To determine the effect of A.annua L and Moringa oleifera leaf powder on CD4 cell count and other immunological indices in HAART HIV patients.

Materials and Methods In this study Artemisia annua leaf powder and Moringa leaf powder will be investigated. The study will be a three arm randomized Phase II study involving adult patients with HIV-infection on HAART with CD4 below 350. The CD4 cell count, and other immunological indices in patients receiving HAART will be compared with those patients receiving additionally Artemisia annua powder with Moringa oleifera powder or Artemisia annua powder alone. The study will be conducted at the HIV clinic in Mbarara Regional Referral Hospital while laboratory tests will be done at Mbarara University of Science and Technology clinical and pharmaceutical sciences laboratories.

Expected outcome The primary outcome will be change in mean (Median) CD 4 cell count. Secondary outcomes will be mean (or median) changes, viral load, complete blood count and other HIV associated immunological indices , Performance status and incidence of adverse effects like nausea, diarrhoea, weight gain and or loss.

Expected benefits Adequate immunological recovery is one of the desired outcomes in HIV care. HAART combinations do not directly aid immunological recovery and some patients fail to have adequate immunological recovery despite adequate suppression of viral load. There are many patients using herbal supplements but there is limited scientific clinical evidence on the benefit of these supplements in HAART patients.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The potential of plant systems to break the HIV-TB link.
   Habibi P, Daniell H, Soccol CR, Grossi-de-Sa MF. · · 2019 · cited 11× · PMID 30908823 · DOI 10.1111/pbi.13110
2. Evaluation of the effects of Artemisia Annua L. and Moringa Oleifera Lam. on CD4 count and viral load among PLWH on ART at Mbarara Regional Referral Hospital: a double-blind randomized controlled clinical trial.
   Twinomujuni SS, Atukunda EC, Mukonzo JK, Nicholas M, et al · · 2024 · cited 2× · PMID 38627722 · DOI 10.1186/s12981-024-00609-4
3. The "Colors" of Moringa: Biotechnological Approaches.
   Villegas-Vazquez EY, Padilla-Mendoza JR, Carrillo-Pérez MS, Gómez-Cansino R, et al · · 2025 · PMID 40805688 · DOI 10.3390/plants14152338