The evaluation of effect of herbal supplement (Melissa Officinalis and Hypericum perforatum along with DDW water) on the improvement of clinical symptoms, CD4 level and the viral load of HIV positive patients: A randomized double blind clinical trial study

To study the effectiveness of HMD 99 capsules formulated with Hypericum p. and Melissa o. extract with deuterium depleted water, on improving the clinical signs, CD4 level and viral load in HIV infected patients

Phase 3 clinical study with 100 patients, double blind and randomized according to a randomized table, with a control group (placebo) and a treatment group (HMD 99 capsules).

After patient selection according to guidelines the study will continue 90 days at the Imam Khomeini hospital in Tehran. Participation in the study is voluntary meaning the patients must volunteer to participate. The assessment of the effectiveness and side effects of the drug will be determined by comparing the results between the control and the treated groups.

Written knowing and voluntary consent, patient age between 18 to 65, patients must have two positive ELISA HIV tests, patients who have failed to benefit from anti-retroviral medication due to drug resistance. Excluded: patients whose blood viral level can not be measured (undetectable), patients with Hepatitis B or C, pregnancy and lactation, patients using immune enhancers within 6 months, current use of drugs or alcohol, use of growth hormone testosterone or anabolic steroids within 30 days prior to entering study, long-term use of immunosuppressants (except for topical steroids); chemotherapy, interferon treatment or radiotherapy (3 weeks prior to entering study)

Experimental group: will receive 3 capsules per day, containing 400 mg formulation of Hypericum p. and Melissa o. extract prepared with deuterium depleted water, for 90 days. Control group: will receive and use 3 capsules per day containing placebo for 90 days.

Laboratory parameters: HIVAb , CBC , ,ALK AST/ALT , BUN , Cr , FBS , Viral load, CD4 level.

A table of randomized numbers (with a number for each patient) shall be used for randomization of treatment in the study. In this table, half the numbers are coded for HMD 99 capsule and the other half for placebo without the administrators prior knowledge. Prescription of HMD 99 capsule or placebo for each patient shall be done by picking numbers from the table and matching them to the code for the medication or placebo.

This is double-blind study in which neither the patients nor the medical care staff/physicians will have information regarding treatment (capsule or placebo) each patient is receiving. The double-blind set up of the study will use coded packages for capsules and placebo which look identical