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

• Sponsor: Trieu, Nguyen Thi, M.D. (Other)
• Overall Status: Completed
• CT.gov ID: NCT04770701
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 61.3
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
HIV-1-infection; AIDS	Drug: Ahah Drug; Device: Ahah Placebo	Phase 4

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

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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: Single (Outcomes Assessor)
• Masking Description: The group of HIV / AIDS uses drugs under study. The group of HIV / AIDS uses a placebo.
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: Dec 1, 2015
• Actual Primary Completion Date: Jan 8, 2021
• Actual Study Completion Date: Jan 10, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The CD4 cell count measurement [- 9 months]

   HIV is a fatal infection, characterized by the targeting and destruction of CD4 T lymphocytes in the peripheral blood.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saigon Biopharma Company Limited	Ho Chi Minh City		Vietnam	700000

Sponsors and Collaborators

• Trieu, Nguyen Thi, M.D.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Trieu, Nguyen Thi, M.D.
• ClinicalTrials.gov Identifier: NCT04770701
• Other Study ID Numbers: HIV / AIDS
• First Posted: Feb 25, 2021
• Last Update Posted: Feb 25, 2021
• Last Verified: Feb 1, 2021

• 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

Study Results

No Results Posted as of Feb 25, 2021