A single-centered pilot scale study to evaluate the safety and efficacy of orally administered supplement SJ29 Capsule in sickle cell anemia patients
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- 1. To evaluate the efficacy of the intervention. (from day 1 to day 60)
研究概览
简要总结
A single-centered pilot scale study to evaluate the safety and efficacy of orally administered supplement SJ29 Capsule in sickle cell anemia patients.
Male or female patients with age over 18 to 30 years diagnosed with sickle cell anemia will be included. Total subject population is 10 subjects. Treatment period is from the day of screening i.e. day 1 to end of intervention of the supplement day 60. Study product is SJ29 Capsule, which subjects to receive daily oral dosing (3 capsules) of natural supplement from day 1 to day 60. Safety of the study intervention will evaluated by lab Investigations parameters: CBC with ESR, Reticulocyte count, LFT, LDH, C-Reactive Protein (CRP), Sickling test, Sr. creatinine, Urine analysis form mean change in these lab parameters from day 1 to end of study visit day 60. The efficacy of study intervention is evaluated by the McGill Pain Questionnaire (Pain tool). The benefit evaluation for this study is grounded in the potential positive impact of SJ29 capsule on sickle cell anemia. This supplement contains compounds that can help reduce the frequency and severity of painful episodes experienced by the patients suffering from sickle cell anemia, thus improving the overall quality of life for individuals. Supplement like this contain nutrients or bioactive compounds that support the function of red blood cells, potentially reducing the likelihood of sickle-shaped cells forming and causing blockages in blood vessels. This supplement is made of 100% herbal formula and helps to reduce the fatigue and pain. It also helps to regenerate healthy new RBC. The benefit evaluation is aligned with the broader goal of enhancing treatment options for sickle cell anemia and promoting overall health in affected individuals. The formulation of the capsule includes Boerhvia diffusa, Calotropis gigantea purified, Coscinium Fenestratum and Curcuma longa. SJ 29 capsule acts selectively to destroy diseased hemoglobin and blast cells. Overall, SJ29 improve the quality of life of patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female over 18 to 30 years, both inclusive.
- •non smokers.
- •BMI greater than 18 kg/m
- •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).
- •Hemoglobin levels between 5.5 and 10.5 g/dl during screening (for newly diagnosed or patients not on any treatment for SCD).
- •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.
- •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)
- •Patient or the patients legally authorized representative has given written informed consent.
- •Able and willing to follow all study related instructions.
- •Must be willing to give written informed consent and comply with the study procedures.
排除标准
- •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.
结局指标
主要结局
1. To evaluate the efficacy of the intervention. (from day 1 to day 60)
时间窗: Day 1 and Day 60
次要结局
- 1. To evaluate the safety of the intervention.(2. Reduction in pain and fatigue of the sickle cell anemia patients.)
研究者
Dr K Sunil Naik
Government Medical College and Govt General Hospital