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

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.

Study Overview

• Status: Completed
• Conditions: HIV-1-infection; AIDS
• Intervention / Treatment: Drug: Ahah Drug; Device: Ahah Placebo

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam, 700000
    • Saigon Biopharma Company Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ahah drug; 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 200mg, dioscorea cirrhosa 200mg, phyllanthus urinaria 150mg, adenosma glutinosum 150mg, impatiens balsamina 75mg and ascorbic acid 250mg	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.; Other Names: Ahah
EXPERIMENTAL: Ahah Placebo; 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 placebo (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)	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.; Other Names: Ahah

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Trieu, Nguyen Thi, M.D.
• Investigators: Principal Investigator: Tran Minh Duc, Dr., Trieu, Nguyen Thi, M.D.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2015
• Primary Completion (ACTUAL): January 8, 2021
• Study Completion (ACTUAL): January 10, 2021

Study Registration Dates

• First Submitted: January 3, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (ACTUAL): February 25, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 25, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: HIV / AIDS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No