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Evaluation of Artemisia Annua and Moringa

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ClinicalTrials.gov Identifier: NCT03366922
Recruitment Status : Recruiting
First Posted : December 8, 2017
Last Update Posted : September 12, 2018
Sponsor:
Collaborator:
ANAMED
Information provided by (Responsible Party):
Mbarara University of Science and Technology

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.


Condition or disease Intervention/treatment Phase
HIV Infections Dietary Supplement: Artemisia Annua, Moringa oleifera Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Double (Participant, Care Provider)
Masking Description:
  • 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.
Primary Purpose: Treatment
Official Title: EVALUATION OF THE EFFECT OF ARTEMISIA ANNUA AND MORINGA OLEIFERA ON IMMUNOLOGICAL RESPONSE IN HAART HIV PATIENTS at MRRH
Actual Study Start Date : December 10, 2017
Estimated Primary Completion Date : December 10, 2019
Estimated Study Completion Date : December 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Active Comparator: Control Arm
Participants will be on routine HAART only. No Artemisia Annua, Moringa oleifera will be given.
Dietary Supplement: Artemisia Annua, Moringa oleifera
As described above

Experimental: Intervention Arm 1
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
As described above

Experimental: Intervention Arm 2
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
As described above




Primary Outcome Measures :
  1. CD4 counts [ Time Frame: Baseline, 6 and 12 months ]
    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.


Secondary Outcome Measures :
  1. Viral load [ Time Frame: Baseline, 6 and 12 months ]
    Viral load at baseline, 6 and 12 months from time of initiating herbal treatment with the above mentioned herbs.

  2. Complete Blood Count [ Time Frame: Baseline, 6 and 12 months ]
    Complete Blood Count at baseline, 6 and 12 months

  3. Immunoglobins [ Time Frame: Baseline, 6 and 12 months ]
    Immunoglobins (E, A, G) associated with HIV infections in HAART patients at baseline, 6 and 12 months

  4. Antiretroviral plasma drug level [ Time Frame: Baseline, one and two weeks ]
    Antiretroviral plasma drug level in HAART patients at baseline and after one and two weeks

  5. Quality of life [ Time Frame: Baseline, 6 and 12 months ]
    WHO Quality of life Tool-HIV

  6. Liver function biomarkers [ Time Frame: Baseline, 6 and 12 months ]
    Liver function biomarkers at baseline, six and twelve months

  7. Side effects or adverse drug reactions [ Time Frame: Baseline, 12 months ]
    Incidence of side effects or adverse drug reactions in the study participants over the study period

  8. Renal function biomarkers [ Time Frame: Baseline, 6 and 12 months ]
    Renal function biomarkers at baseline, six and twelve months



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Participant is 18 years of age and above
  2. Participant is HIV positive
  3. Participant is on HAART first line for at least one year.
  4. Participant is mentally sound
  5. 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

Exclusion Criteria:

  1. Participant is pregnant
  2. Participant does not consent to study
  3. Participant with opportunistic infection
  4. Participants using other herbal medicines
  5. Participant living outside the radius of 60 km from the clinic

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03366922


Contacts
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Contact: Esther C Atukunda, PhD +256702949832 eatukunda@must.ac.ug
Contact: Patrick Ogwang, PhD +256779617612 pogwang@must.ac.ug

Locations
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Uganda
Mbarara Regional Referral Hospital Recruiting
Mbarara, SouthWestern, Uganda, 00256
Contact: Bosco Bwana, MD    +256772308895    bbwana@must.ac.ug   
Contact: Winnie Muyindike, MD    +256772521619    wmuyindike@gmail.com   
Sponsors and Collaborators
Mbarara University of Science and Technology
ANAMED

Publications:
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Responsible Party: Mbarara University of Science and Technology
ClinicalTrials.gov Identifier: NCT03366922     History of Changes
Other Study ID Numbers: 27/05-17
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Participant lab results will be availed to the attending physician

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases