To evaluate the safety and efficacy of orally administered supplement SJ29 Capsule in sickle cell anemia patients

A single-centered pilot scale study to evaluate the safety and efficacy of orally administered supplement SJ29 Capsule in sickle cell anemia patients

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/07/070723

Enrollment

Registered

2024-07-16

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Health Condition 1: D571- Sickle-cell disease without crisis

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female over 18 to 30 years, both inclusive. 2. non smokers. 3. BMI greater than 18 kg/m2. 4. Patients diagnosed with sickle cell disease (documented by hemoglobin electrophoresis) and carrying SS or Sbeta0 version of the beta globin gene (documented by genotyping, known through medical history). 5. Hemoglobin levels between 5.5 and 10.5 g/dl during screening (for newly diagnosed or patients not on any treatment for SCD). 6. If the patient has been treated with an anti-sickling agent within three months with the intent to continue for the duration of the study. 7. Available to attend on an outpatient basis for visits provided for in the protocol and able to complete the data collection documents (compliance and quality of life scale) 8. Patient or the patients legally authorized representative has given written informed consent. 9. Able and willing to follow all study related instructions. 10. Must be willing to give written informed consent and comply with the study procedures.

Exclusion criteria

Exclusion criteria: 1.Females who are pregnant or breastfeeding. 2.Patient has a significant medical condition that required hospitalization (other than sickle cell crisis) within two months of the screening visit. 3.Patient with diagnosed cancer in the past 2 years. 4.Patients participating simultaneously in another clinical research protocol or having recently participated in another research for which the exclusion period has not been completed. 5.Majors under legal protection or unable to express their consent. 6.People in an emergency situation unable to express their prior consent.

Design outcomes

Primary

Measure	Time frame
1. To evaluate the efficacy of the intervention. (from day 1 to day 60)Timepoint: Day 1 and Day 60	—

Secondary

Measure	Time frame
1. To evaluate the safety of the intervention. 2. Reduction in pain and fatigue of the sickle cell anemia patients. 3. Number of days hospitalised due to acute SCD complications. 4. To improve the quality of life of patient.Timepoint: Day 1 and Day 60	—

Countries

India

Contacts

Public ContactMr Manik Chaudhuri

Xplora Clinical Research Services Pvt. Ltd

hasan@xplorahealth.com9886012598

Outcome results