CTRI/2022/02/040494已完成不适用
A Prospective, Double Blind, Randomized, Parallel, Single-Center, Two-Arm, Placebo Controlled Clinical Study to Assess the Efficacy and Safety of KSM-66 Ashwagandha®capsule (300 mg) on Immune Function Enhancement and Quality of Life (QoL) in Healthy Subjects
Ixoreal Biomed1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年2月28日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in mean levels of Serum Immune Biomarkers (NK Cell, CD4, CD8-T-Lymphocytes)
研究概览
简要总结
Sixty healthy male or female subjects of age 18-60 will be assigned in 1:1 ratio to treatment with the test product, KSM-6 Ashwagandha capsules or Placebo in this double-blind, randomized, placebo-controlled study. All 60 enrolled subjects will be instructed to take two capsules of either KSM-66 Ashwagandha or Placebo twice a day one capsule after breakfast and one capsule after dinner for 56 days daily. 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 immune biomarkers in blood and secondarily with administration of immune health questionnaire, SF 12, PSS 10 and PGATT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult males and females between 18 to 60 years of age.
- •(Apparently healthy, as determined by medical history, physical examination)
- •Subjects with Immune Status Questionnaire of less than 6
- •Participants who agree to take investigational product (i.e., Till day 56)
- •Literate subject willing to give signed informed consent.
- •Willing to comply with study protocol requirements.
排除标准
- •Participants who are not willing to take investigational product.
- •Any acute illness which may hamper the study participation as per PI discretion at the time of enrollment.
- •Individual participating in any other studies, including macro/micro/any other forms of dietary supplements/multivitamins or disease-specific oral nutrition supplements.
- •Patients with uncontrolled, unstable comorbidities.
- •Individuals with pre-existing respiratory conditions or diagnostic history with chronic lung disease, active malignancy, chronic kidney disease, chronic liver disease.
- •History of allergic reactions or anaphylaxis to investigational product components.
- •Participants with a history of or those currently on immunosuppressants.
- •Pregnant and lactating females.
- •Any other condition which the principal investigator thinks may jeopardize the safety of subjects—patients with uncontrolled, unstable comorbidities.
- •Those with a history of clinically significant hypersensitivity reactions to immunomodulators.
- •Those with thyroid or pituitary disease
- •Those with immune system disease
- •Those with a history of systemic diseases such as multiple sclerosis, allergic skin disease and other autoimmune diseases
- •Those with a BMI of less than 18.5 kg/m2 at screening
- •Those who have received antipsychotic medication within 2 months before screening
- •Those with a alcoholism or history of substance abuse
- •Fertile women who do not accept the appropriate method of contraception (except for women who have undergone sterilization operation)
- •Participation in a clinical study during the preceding 90 days.
结局指标
主要结局
Change in mean levels of Serum Immune Biomarkers (NK Cell, CD4, CD8-T-Lymphocytes)
时间窗: Baseline and Day 56
次要结局
- •Change in mean levels of Serum Immune Biomarkers (IgA, IgG, IL-6, Interferon-Gamma, TNF-alpha levels) from baseline to end of study. (Time Frame: Baseline, Day 56)(•Number of Individuals displaying the improvement of Immune Health Status (questionnaire) between the groups. (Time Frame: Baseline, Day 56))
研究者
研究点 (1)
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