CTRI/2025/06/089663尚未招募不适用
A randomized, double-blind, placebo-controlled study to evaluate the efficacy of Theolim (CL19183) in mitigating gradual loss of muscle strength and associated symptoms of aging in healthy adults.
CLS Pvt. Ltd1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2025年8月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Change from baseline to end of the study in Quadriceps strength using (1RM) using leg extension exercise
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of CL19183 in mitigating gradual loss of muscle strength and associated symptoms of aging in healthy adults and to evaluate tolerability and changes in body composition of the study participants.
A total of 108 male and female subjects aged between 55 and 85 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer-generated randomization list.
The subjects will be assigned to either CL19183 -450mg, or placebo arms at 1:1 ratio. The subjects will be instructed to take one capsule daily in the morning after breakfast with water on scheduled visits.
Apart from primary and secondary outcomes, the study will also record the vital signs and adverse events to evaluate the herbal composition safety and tolerability.
The safety assessment of the CL19183 will also include routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 55.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy subjects aged 55-85 years (5 years post menopause in women and men greater than 65 yrs.
- •of age) with a Body Mass Index (BMI) of between 22 and 29.9 kg/m
- •Subjects with hand-grip strength will be greater than 28 kg for men and greater than 18 kg for women; (AWGS, 2019).
- •Subjects who score above 9 in the SPPB (Short Physical Performance Battery) tests.
- •Subjects agreed to get assessed for physical activity using (Global Physical Activity Questionnaire) GPAQ.
- •Subjects willing to participate in warming up followed by brisk walking exercise (5 days a week, 30 min per day) over study duration.
- •Subjects with clinical lab observations within normal range or considered not clinically significant by the principal investigator.
- •Subjects who are not nutritionally deprived or malnourished assessed using MNA-SF.
- •Willing to keep dietary records to allow macronutrient intake to be calculated during the study period.
排除标准
- •Subjects having allergy or hypersensitivity to any of the ingredients in the investigational products.
- •Subjects with any pre-existing medical conditions which in the opinion of the investigator makes the subject unsuitable for inclusion.
- •Subjects underwent treatment for COVID-19 or tested positive during the study will be excluded.
- •Subjects who are receiving treatment for serious diseases (e.g., cardiovascular, immunological, respiratory, hepatobiliary, renal, neurological, musculoskeletal, mental, and infectious diseases, or malignant tumor).
- •Subjects with TSH levels lesser than or equal to 0.1 µIU/mL or greater than or equal to 10 µIU/mL, Creatinine levels greater than 2 mg/dl and AST or ALT levels 3X higher than the normal standard.
- •Serious musculoskeletal abnormalities or damage to the lower extremities.
- •History of cancer within 5 years or are currently being treated (except for skin tumors other than melanoma).
- •Use of functional food or supplement for muscle strength improvement within prior two weeks.
- •Subjects who participated in resistance exercise within three months prior to the first/screening visit.
- •Subjects who participated in other interventional clinical trial in past three months.
- •Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
- •Any surgery or fracture in lower limb in past 6 months or any impairment or disease severely affecting gait (e.g. Parkinsons disease, peripheral polyneuropathy, intermittent claudication in advanced peripheral vascular disease, spinal stenosis, or severe osteoarthritis of the knee or hip with ineffective pain management).
- •Subjects with diabetes (FBS greater than or equal to 126 mg/dL), hypertension (Systolic greater than 140 and Diastolic greater than 90 mmHg).
- •Subjects consuming excessive amounts of alcohol (more than 5 drinks per week) and smoking more than 5 cigarettes per day within three months.
- •Subjects using any dietary supplements that could interfere with the study outcomes, including protein, amino acids, leucine, beta-alanine, HMB, creatine or other supplements known to impact muscle.
- •Subjects under medications including anti-hypertensives, inhaled beta agonists, anti-hyperlipidemics, psychotropic etc.
- •Confirmed rheumatoid arthritis or other systemic autoimmune disease requiring immunosuppressive therapy or corticosteroids.
- •Myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention (e.g. angioplasty or stent placement), or deep vein thrombosis/pulmonary embolism within 12 weeks prior to screening.
- •Subjects with HIV positive or any other STDs. 21.
结局指标
主要结局
Change from baseline to end of the study in Quadriceps strength using (1RM) using leg extension exercise
时间窗: Week 0 (Baseline), Week 2, Week 4, Week 8, Week 12 and Week 16.
次要结局
- Changes in body fat mass (%), (kg) through DEXA(Week 0 (Baseline), Week 8 and Week 16.)
- Change in Body fat ratio (muscle/fat) measured by DEXA(Week 0 (Baseline), Week 8 and Week 16.)
- Change in Grip strength (Using digital hand dynamometer)(Screening visit, Week 0 (Baseline), Week 2, Week 4, Week 8, Week 12 and Week 16.)
- Six minute walk test (V2 to V7)(Week 0 (Baseline), Week 2, Week 4, Week 8, Week 12 and Week 16.)
- Degree of change in SMI (ASM/ height2) using DEXA(Week 0 (Baseline), Week 8 and Week 16.)
- Change in Skeletal muscle mass (SMM) using an appropriate method measured by DEXA(Week 0 (Baseline), Week 8 and Week 16.)
- Change in ASM/weight x 100(Week 0 (Baseline), Week 8 and Week 16.)
- Change in Quality of Life Questionnaire (EQ- 5D- 3L)(Week 0 (Baseline), Week 2, Week 4, Week 8, Week 12 and Week 16.)
- Change in Fasting Insulin(Week 0 (Baseline) and Week 16.)
- Change in Hs-CRP concentration and Sarcopenia Index (based on Serum creatinine& Serum Cystatin C)(Week 0 (Baseline) and Week 16.)
- Change in Antioxidant Index: MDA(Week 0 (Baseline) and Week 16.)
- Change in Antioxidant enzyme activity (GPX, GSH, SOD, CAT)(Week 0 (Baseline) and Week 16.)
- Change in Isokinetic exercise to confirm quadriceps and hamstrings strength using Easyforce(Week 0 (Baseline) and Week 16.)
- Change in Timed up and go, TUG(Week 0 (Baseline) and Week 16.)
- Change in Inflammatory cytokine (TNF-alpha, IL-1, IL-6) production level.(Week 0 (Baseline) and Week 16.)
研究者
研究点 (1)
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