HIV-1-infectionPhase 4NCT04770701
Protect and Improve Cluster of Differentiation 4 (CD4) Cells and B Cells Lymphocytes
A Phase 4 study testing Ahah Drug in people with HIV-1-infection and AIDS, run by Trieu, Nguyen Thi, M.D. at 1 site in Vietnam.
Trial summary
This is a plant-based medication used to increase the amount, protect, and reduce HIV's impact on T and B lymphocytes. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV-1-infection, AIDS
- What is being tested?
- Ahah Drug
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteVietnam
- Study dates
- 20 Sep 2020to 6 Jun 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants have a decline in CD4 + T-lymphocytes is the hallmark of HIV-1 infection.
- Characterized by rapid loss of resistance: AIDS
- Dermatitis, mouth ulcers, skin rash, itching, weight loss
- HCV (+), HBV (+), Tuberculosis (+)
Who cannot join
- Cancer under all form
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Extracts of Plants Eclipta Prostrata, Dioscorea Cirrhosa, Phyllanthus Urinaria, Adenosma Glutinosum, Impatiens Balsamina and Ascorbic Acid Use for in Protecting and Increasing CD4+ T Lymphocytes; B Lymphocytes Level in HIV/AIDS Patients.
This is a plant-based medication used to increase the amount, protect, and reduce HIV's impact on T and B lymphocytes.
Read the detailed description
Dioscorea cirrhosa, impatiens balsamina, eclipta prostrata, phyllanthus urinaria, adenosma glutinosum, and ascorbic acid are used to elevate T and B lymphocytes level, protect their cells membrane, decrease the damage of HIV on CD4+ T.
In detail, Diosgenin presented in dioscorea cirrhosa is a precursor of cortisol. Dioscorea cirrhosa when combined with ascorbic acid helps to balance cortisol levels which reduces cell inflammation. Flavonoids of dioscorea cirrhosa also help to increase CD4+ T levels.
impatiens balsamina can be used as an antitoxin alternative against bacteria or viruses. Flavonoids in impatiens balsamina, such as kaempferol, quercetin, rutin, astragalin, have the ability to reduce the virus's impact on T lymphocyte, protect their cell membrane, produce antihistamine, protect the cell from inflammation.
Targeted flavonoids in eclipta prostrata, phyllanthus urinaria, adenosma glutinosum are used to cell repair, protect and increase CD4+ T production.
Ascorbic acid in combination with herbal extracts creates a favorable environment for body metabolism, improves the medication's effectiveness.
- Conditions
- HIV-1-infection, AIDS
- Being tested
- Ahah Drug, Ahah Placebo
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ahah DrugDrug
Also called Ahah
- Composition Ahah containing concentrated extracts of plants: Eclipta prostrata, dioscorea cirrhosa, phyllanthus urinaria, adenosma glutinosum, impatiens balsamina and ascorbic acid.
-Take 1tablet x 2 times / 24 hours. Maintained for 9 months.
Ahah PlaceboDevice
Also called Ahah
- Composition Ahah (not containing concentrated extracts of plants): Eclipta prostrata, dioscorea cirrhosa, phyllanthus urinaria, adenosma glutinosum, impatiens balsamina and ascorbic acid.
-Take 1tablet x 2 times / 24 hours. Maintained for 9 months.
| Study group | Role | What they receive |
|---|---|---|
| Ahah drug | Experimental | Participants have a decline in CD4 + T-lymphocytes is the hallmark of the human immunodeficiency virus (HIV)-1 infection.
Characterized by rapid loss of resistance: AIDS
* Dermatitis, mouth ulcers, skin rash, itching, weight loss
* Hepatitis C virus (HCV) (+), Hepatitis B virus (HBV) (+), Tuberculosis (+)
Ahah composition contains the following ingredients (concentrated extracts of plants):
Eclipta prostrata, dioscorea cirrhosa, phyllanthus urinaria, adenosma glutinosum, impatiens balsamina and ascorbic acid Receives: Drug: Ahah Drug; Device: Ahah Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The CD4 cell count measurement
HIV is a fatal infection, characterized by the targeting and destruction of CD4 T lymphocytes in the peripheral blood.
Measured: - 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start20 Sep 2020
- Primary completion7 Jun 2025
- Study completion6 Jun 2026 (estimated)
Why it stopped: The study was withdrawn before enrollment due to administrative and board approval constraints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 60 people were recruited HIV / AIDS positive between the ages of 20 and 60 and divided into 2 groups according to a random distribution.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trieu, Nguyen Thi, M.D.
- Responsible party
- Sponsor
- Investigators
- Tran Minh Duc, Dr., Principal investigator, Trieu, Nguyen Thi, M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04770701
- Sponsor's protocol ID
- HIV / AIDS
- Status last verified
- Jun 2026
- First submitted
- 3 Jan 2021
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracts of Plants Eclipta Prostrata, Dioscorea Cirrhosa, Phyllanthus Urinaria, Adenosma Glutinosum, Impatiens Balsamina and Ascorbic Acid Use for in Protecting and Increasing CD4+ T Lymphocytes; B Lymphocytes Level in HIV/AIDS Patients.
- ClinicalTrials.gov ID
- NCT04770701
- Acronym / sponsor ID
- HIV / AIDS
- Conditions
- HIV-1-infection, AIDS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn before enrollment due to administrative and board approval constraints.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Trieu, Nguyen Thi, M.D.
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 7 Jun 2025 (actual)
- Study completion
- 6 Jun 2026 (estimated)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a plant-based medication used to increase the amount, protect, and reduce HIV's impact on T and B lymphocytes.
Detailed description
Dioscorea cirrhosa, impatiens balsamina, eclipta prostrata, phyllanthus urinaria, adenosma glutinosum, and ascorbic acid are used to elevate T and B lymphocytes level, protect their cells membrane, decrease the damage of HIV on CD4+ T.
In detail, Diosgenin presented in dioscorea cirrhosa is a precursor of cortisol. Dioscorea cirrhosa when combined with ascorbic acid helps to balance cortisol levels which reduces cell inflammation. Flavonoids of dioscorea cirrhosa also help to increase CD4+ T levels.
impatiens balsamina can be used as an antitoxin alternative against bacteria or viruses. Flavonoids in impatiens balsamina, such as kaempferol, quercetin, rutin, astragalin, have the ability to reduce the virus's impact on T lymphocyte, protect their cell membrane, produce antihistamine, protect the cell from inflammation.
Targeted flavonoids in eclipta prostrata, phyllanthus urinaria, adenosma glutinosum are used to cell repair, protect and increase CD4+ T production.
Ascorbic acid in combination with herbal extracts creates a favorable environment for body metabolism, improves the medication's effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 60 people were recruited HIV / AIDS positive between the ages of 20 and 60 and divided into 2 groups according to a random distribution.
| Arm | Type | Receives |
|---|---|---|
| Ahah drug | Experimental | Drug: Ahah Drug, Device: Ahah PlaceboParticipants have a decline in CD4 + T-lymphocytes is the hallmark of the human immunodeficiency virus (HIV)-1 infection. Characterized by rapid loss of resistance: AIDS * Dermatitis, mouth ulcers, skin rash, itching, weight loss * Hepatitis C virus (HCV) (+), Hepatitis B virus (HBV) (+), Tuberculosis (+) Ahah composition contains the following ingredients (concentrated extracts of plants): Eclipta prostrata, dioscorea cirrhosa, phyllanthus urinaria, adenosma glutinosum, impatiens balsamina and ascorbic acid |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants have a decline in CD4 + T-lymphocytes is the hallmark of HIV-1 infection.
- Characterized by rapid loss of resistance: AIDS
- Dermatitis, mouth ulcers, skin rash, itching, weight loss
- HCV (+), HBV (+), Tuberculosis (+)
Key exclusion criteria (1 listed)
- Cancer under all form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ahah DrugAlso: Ahah- Composition Ahah containing concentrated extracts of plants: Eclipta prostrata, dioscorea cirrhosa, phyllanthus urinaria, adenosma glutinosum, impatiens balsamina and ascorbic acid. -Take 1tablet x 2 times / 24 hours. Maintained for 9 months. | Drug | Ahah drug |
| Ahah PlaceboAlso: Ahah- Composition Ahah (not containing concentrated extracts of plants): Eclipta prostrata, dioscorea cirrhosa, phyllanthus urinaria, adenosma glutinosum, impatiens balsamina and ascorbic acid. -Take 1tablet x 2 times / 24 hours. Maintained for 9 months. | Device | Ahah drug |
Primary outcome
The CD4 cell count measurement
Time frame: - 9 months
HIV is a fatal infection, characterized by the targeting and destruction of CD4 T lymphocytes in the peripheral blood.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tran Minh Duc, Dr. principal investigator
Trieu, Nguyen Thi, M.D.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ahah Drug in people with HIV-1-infection and AIDS, run by Trieu, Nguyen Thi, M.D. at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The CD4 cell count measurement (time frame: - 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.