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A clinical trial to study the effect of RECEPTOL® , a pure natural nano peptide - antiviral and immunomodulator drug, in patients with HIV / AIDS

An Interventional / Prospective Phase III Accelerated Study to Determine The Efficacy & Safety of RECEPTOL Oral Spray Used As A Stand-Alone Mono Therapy In HIV / AIDS Patients with multiple symptoms

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/08/002931
Enrollment
50
Registered
2012-08-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- HIV/AIDS

Interventions

Intervention1: Receptol: Viral Load and clinical symptoms and increase in Absolute CD4 cell count and change in body weight,HIV related Fatigue/Malaise, Diarrhoea, Nausea, Vomiting, Fever, Cough, Para

Sponsors

Biomix Network Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The study will include the patients satisfying the following eligibility criteria: 1) Male and Female subjects between 18 and 60 years of age. 2) Documentation of HIV infection by any approved ELISA test, and the disease contracted heterosexually (no drug abuse) preferably within six months of participation in this trial. 3) With CD4 count greater than 100 cells/cmm 4) With a measurable HIV viral load 5) Subjects willing to give informed consent for their stay in the hospital and / or follow up visits.

Exclusion criteria

Exclusion criteria: The study will include the patients satisfying the following eligibility criteria: 1.Pregnant or nursing women, women of childbearing potential not using an adequate method of 2.birth control. 3. Subjects with kidney failure with Serum Creatinine greater than 1.5 mg/dL. 4. With a history of Hepatic Cirrhosis. 5. Suffering from Congestive Heart Failure (CHF). 6. With current alcohol or substance abuse that could interfere with patient compliance. 7. Organ transplant recipient.

Design outcomes

Primary

MeasureTime frame
The primary outcome measures will be all cause mortality at 3 weeks of 12 weeks therapy showing mark improvement in clinical and physical symptoms of weight gain, absolute CD4 counts and viral load reduction in all HIV positive patients (some opportunistic infections viz TB) and mark improvement in quality of life within first 3 weeks standalone mono-therapy (without ART/DOTS).Timepoint: first 3 weeks

Secondary

MeasureTime frame
12 weeks Receptol alone mono therapy showed mark improvement in quality of life .Timepoint: 12 weeks

Countries

India

Contacts

Public ContactDr Pawan Saharan

Biomix Network Ltd.

biomix@amuldairy.com09323000880

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026