Protect and Improve Cluster of Differentiation 4 (CD4) Cells and B Cells Lymphocytes

HIV-1-infection Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04770701
• Other study ID #: HIV / AIDS
• Status: Completed
• Phase: Phase 4
• Start date: December 2015
• Est. completion date: January 10, 2021

Study information

• Verified date: February 2021
• Source: Triê?u, Nguyê~n Thi?, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a plant-based medication used to increase the amount, protect, and reduce HIV's impact on T and B lymphocytes.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 10, 2021
• Est. primary completion date: January 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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 (+)

Exclusion Criteria:

• Cancer under all form

Related Conditions & MeSH terms

• AIDS
• HIV-1-infection

Intervention

Drug:
• Ahah Drug
- Composition Ahah containing concentrated extracts of plants: Eclipta prostrata 200mg, dioscorea cirrhosa 200mg, phyllanthus urinaria 150mg, adenosma glutinosum 150mg, impatiens balsamina 75mg and ascorbic acid 250mg -Take 1tablet x 2 times / 24 hours. Maintained for 9 months.

Device:
• Ahah Placebo
- Composition Ahah (not containing concentrated extracts of plants): Eclipta prostrata 200mg, dioscorea cirrhosa 200mg, phyllanthus urinaria 150mg, adenosma glutinosum 150mg, impatiens balsamina 75mg and ascorbic acid 250mg) -Take 1tablet x 2 times / 24 hours. Maintained for 9 months.

Locations

Country	Name	City	State
Vietnam	Saigon Biopharma Company Limited	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Triê?u, Nguyê~n Thi?, M.D.

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The CD4 cell count measurement	HIV is a fatal infection, characterized by the targeting and destruction of CD4 T lymphocytes in the peripheral blood.	- 9 months