Evaluation of Artemisia Annua and Moringa

NCT03366922 | Completed DMC

• 1 other identifier: 27/05-17
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

• CD4 counts

  The primary outcome will be change in CD4 counts (absolute and relative) at 6 and 12 months in study participants following enrollment in the study.

  Baseline, 6 and 12 months

Secondary Outcomes (8)

• Viral load

  Baseline, 6 and 12 months

• Complete Blood Count

  Baseline, 6 and 12 months

• Immunoglobins

  Baseline, 6 and 12 months

• Antiretroviral plasma drug level

  Baseline, one and two weeks

• Patients perceptions on mental and physical quality of life

  Baseline, 6 and 12 months

Study Arms (3)

Control Arm

ACTIVE COMPARATOR

Participants will be on routine HAART only. No Artemisia Annua, Moringa oleifera will be given.

Dietary Supplement: Artemisia Annua, Moringa oleifera

Intervention Arm 1

EXPERIMENTAL

Participants will be given HAART and Artemisia annua leaf powder 4 g per day. They will only receive Artemisia Annua, Moringa oleifera will not be given.

Dietary Supplement: Artemisia Annua, Moringa oleifera

Intervention Arm 2

EXPERIMENTAL

Participants will be given HAART with Artemisia annua leaf powder of 4 grams per day and Moringa oleifera leaf powder of 10 grams per day. Both Artemisia Annua, Moringa oleifera will be given.

Dietary Supplement: Artemisia Annua, Moringa oleifera

Interventions

Artemisia Annua, Moringa oleifera DIETARY_SUPPLEMENT

As described above

Control Arm; Intervention Arm 1; Intervention Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is 18 years of age and above
• Participant is HIV positive
• Participant is on HAART first line for at least one year.
• Participant is mentally sound
• Participant is living within 60 km radius from the clinic and will be remaining within the radius of 60 km from the clinic during the study period
• h) Participant has a CD4 count less than 350cells/µl i.)Participant has normal haematological and biochemical indices J) ability to use phone SMS messaging K) Participant has signed the informed consent form

You may not qualify if:

• Participant is pregnant
• Participant does not consent to study
• Participant with opportunistic infection
• Participants using other herbal medicines
• Participant living outside the radius of 60 km from the clinic

Sponsors & Collaborators

• Mbarara University of Science and Technology: lead
• ANAMED: collaborator

Study Sites (1)

Mbarara Regional Referral Hospital

Mbarara, SouthWestern, 00256, Uganda

Location

Related Publications (4)

• Alin MH, Ashton M, Kihamia CM, Mtey GJ, Bjorkman A. Clinical efficacy and pharmacokinetics of artemisinin monotherapy and in combination with mefloquine in patients with falciparum malaria. Br J Clin Pharmacol. 1996 Jun;41(6):587-92. doi: 10.1046/j.1365-2125.1996.35116.x.

  PMID: 8799526 BACKGROUND

• Ashton M, Gordi T, Trinh NH, Nguyen VH, Nguyen DS, Nguyen TN, Dinh XH, Johansson M, Le DC. Artemisinin pharmacokinetics in healthy adults after 250, 500 and 1000 mg single oral doses. Biopharm Drug Dispos. 1998 May;19(4):245-50. doi: 10.1002/(sici)1099-081x(199805)19:43.0.co;2-z.

  PMID: 9604124 BACKGROUND

• Zhao KC, Song ZY. [Pharmacokinetics of dihydroqinghaosu in human volunteers and comparison with qinghaosu]. Yao Xue Xue Bao. 1993;28(5):342-6. Chinese.

  PMID: 8237378 BACKGROUND

• Twinomujuni SS, Atukunda EC, Mukonzo JK, Nicholas M, Roelofsen F, Ogwang PE. 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. AIDS Res Ther. 2024 Apr 16;21(1):22. doi: 10.1186/s12981-024-00609-4.

  PMID: 38627722 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: * Two research assistants will be recruited and trained as observers and data collectors to increase accuracy and consistency in documenting the needed data. They will be assisted by the HIV clinic staff and these research assistants will be blinded to the hypotheses of this study to minimize observer bias and facilitate participant randomization. Senior clinician at the HIV clinic will supervise the trial and administration of treatments for HAART patients attending at the MRRH clinic. * To endure blinding, a study nurse will randomize and interview the participants and or draw blood whenever necessary. Study phlebotomist will draw blood and deliver it to the respective laboratory with codes masking the arm in which that patient is randomized. Independent laboratory technicians will run the tests at Epicenter and MUST research Labs.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be stratified according to baseline CD4 levels: 350 - 250, 249 - 150, below 149. Computer generated numbers will be used to assign selected participants into study groups using simple randomization method to either control group with HAART only, or HAART with Artemisia annua group or HAART with Artemisia annua and Moringa oleifera group of 1:1:1.

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: December 8, 2017
• Study Start: December 10, 2017
• Primary Completion: August 10, 2020
• Study Completion: August 10, 2020
• Last Updated: November 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)