The effect of licorice capsule on increasing of CD4 plus T lymphocytes counts in HIV patients treated with antiretroviral therapy without immunological response

Increase in CD4 plus T lymphocytes counts using licorice capsule compared to placebo for three months in antiretroviral-treated HIV patients without immunologic response

Two arm parallel groups randomised trial with blinded

Principle researcher evaluates patients at baseline considering inclusion and exclusion criteria and informed consent was obtained. CD4 plus lymphocyte count, interleukin-7 plasma level, blood pressure, electrolyte levels (sodium and potassium) and creatinine are measured. The demographic characteristics of the participants are fulfilled according to the relevant table. At the end of the first, second, fourth, eighth and twelfth week, side effect checklist including blood pressure, electrolyte levels, and creatinine will be completed by the responsible researcher. If any severe adverse drug effect or abnormal tests observed, the participant will be excluded from the study. Participants are warned about the side effects of licorice capsules and tell to stop taking medication immediately if they have any mentioned side effects. CD4 + lymphocyte count, plasma IL-7 levels were measured at weeks 4, 8, and 12.

Inclusion criteria 1.Confirmation of HIV through ELISA test 2.Receiving antiretroviral therapy for at least one year and HIV viral load less than 50 copies per ml and T CD4 plus lymphocyte count less than 200 cells/µL Exclusion criteria 1.A history of allergies and hypersensitivity reactions to licorice and its compounds 2. Active opportunistic infections at the time of recruitment and at any time during the study

Licorice capsule group: 4 licorice capsules 500 mg daily for three months Placebo group: 4 placebo capsules 500 mg daily for three months

Number of CD4 plus T lymphocytes; interleukin-7 plasma levels

Randomization is done by Permuted-4th block randomization

Solely, the manufacturer knows which group A or B is drug or placebo. Concealment was done by the principal researcher ( as third party concealment) means he only knows the randomization sequence and tells health care provider which participants allocate in group A or B.