A Multicentre, Randomized, Double Blind, Parallel, Placebo Controlled Two Arm Study to Evaluate Safety and Efficacy of Orally Administered Protocatechuic Acid (PCA) capsule/ supplement.
试验速览
- 阶段
- 2 期
- 状态
- Other (Terminated)
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 1. Monitoring and documentation of number and type of adverse events including changes in laboratory parameter (Complete blood count with differential, ESR, kidney function, liver function, lipid profile) from Baseline (Day 1) to the end (Day 14) of the study.
研究概览
简要总结
60 subjects will be screened (Considering 10% screen fail and 5% dropout to achieve 52 completed subjects for analysis). Eligible subjects of age 50- 65 will be assigned in 1:1 ratio to treatment with the test product, PCA Capsule or Placebo in this double- blind, randomized, placebo- controlled, parallel study. All enrolled subjects will be instructed to take 4 capsules of 500 mg (2000mg) of PCA and Placebo, 2 daily in the morning and 2 in evening, 2 hours before breakfast and dinner for 14 days. Subjects will be required to use diaries to document the date, time and dosage of study treatments including any missed doses and the occurrence of any adverse events. The efficacy of investigational product will be assessed primarily with HbA1c, fasting blood glucose & post prandial Sugar, Hs CRP, IGF-1, IgA, IgG, CXCL9, GLP1 & Prothrombin time. Primary objective is To determine safety and tolerability of PCA as compared to placebo in participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects willing to provide a personally signed and dated informed consent prior to any study procedures; willing to comply with the study instructions and attend all scheduled study visits.
- •Males and females with age between 50 and 65 years, both inclusive.
- •Subjects willing to continue with their existing diet, exercise, and lifestyle habits throughout the study, without any change.
- •Subjects willing and able to comply with study procedures and duration.
- •Subjects willing to take the IP as per protocol defined dose and regime.
- •Non-menopausal & non-castrated women those are willing to use reliable methods of contraception to avoid pregnancy during the study.
排除标准
- •Subjects with allergy or sensitivity to any ingredient of Investigational product.
- •Participation in any clinical study within 30 days before randomization.
- •Pregnant and lactating women.
- •Any kind of substance abuse, (alcohol, tobacco, or any other substance).
- •Subjects with uncontrolled metabolic diseases or chronic diseases at the discretion of the Investigator.
- •Subjects with unstable medical conditions as determined by the qualified Investigator.
- •Subjects with any planned surgery during the trial; history of any surgery past 3 months.
- •Current diagnosis of immune-compromised conditions like HIV/AIDS, cancer.
- •History of blood/bleeding disorders; blood donation in the previous 2 months.
- •Individuals who have had COVID-19 in the past three months.
- •Individuals with a history of major arthritis or joint problem.
- •Any other condition that in the qualified investigator’s opinion may have adversely affected the participant’s ability to complete the study or its measures or which may have posed a significant risk to the participant.
结局指标
主要结局
1. Monitoring and documentation of number and type of adverse events including changes in laboratory parameter (Complete blood count with differential, ESR, kidney function, liver function, lipid profile) from Baseline (Day 1) to the end (Day 14) of the study.
时间窗: Day 1, Day 14
次要结局
- 1. To evaluate the efficacy of PCA capsules as compared to placebo based on personal health assessment test through SF 36 Survey, to evaluate the efficacy of PCA capsules as compared to placebo based on laboratory examinations (HbA1c, fasting blood glucose & post prandial Sugar, Hs CRP, IGF-1, IgA, IgG, CXCL9, GLP1 & Prothrombin time).(Day 1, Day 14)
研究者
Dr Ganesh Avhad
Lotus Holistic Healthcare & Aesthetic Clinic