| CTRI Number |
CTRI/2025/06/089663 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
24/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy of CL19183 in mitigating gradual loss of muscle strength and associated symptoms of aging in healthy adults. |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CLS/MW/CL19183/25, Version 01, Dated 25-Apr-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepak Mishra |
| Designation |
Principal Investigator |
| Affiliation |
Kalyan Clinic |
| Address |
Paharia Rd, Paharia Chowk, Sri Nagar Colony, Paharia,
Varanasi
UTTAR PRADESH
221007
India |
| Phone |
7499656541 |
| Fax |
|
| Email |
deepakmishra1979@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tirupathi Rao |
| Designation |
Assistant Manager-Pharmacology |
| Affiliation |
CLS Pvt. Ltd. |
| Address |
Department of Pharmacology, Room No.201, First Floor,
Aswaraopet
Khammam
TELANGANA
507301
India |
| Phone |
8331015082 |
| Fax |
|
| Email |
tirupathionline@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Ajjarapu Srinivasu |
| Designation |
Manager |
| Affiliation |
CLS Pvt Ltd |
| Address |
Room No.101,Ground Floor,
Sales Department, Aswaraopet
Khammam
TELANGANA
507301
India |
| Phone |
9949514689 |
| Fax |
|
| Email |
ajjarapuhimas@gmail.com |
|
|
Source of Monetary or Material Support
|
| CLS Pvt. Ltd,Aswaraopet,
Khammam District,
Telangana, Pin Code: 507301 |
|
|
Primary Sponsor
|
| Name |
CLS Pvt. Ltd |
| Address |
Aswaraopet,
Khammam District,
Telangana, Pin Code: 507301 |
| Type of Sponsor |
Other [Nutraceutical Industry] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepak Mishra |
Kalyan Clinic |
Ashapur Road, near City Honda,Paharia,Varanasi
Varanasi
UTTAR PRADESH |
7499656541
deepakmishra1979@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Upendra Medicare Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Age related muscle weakness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CL19183 450mg |
One capsule daily in the morning after breakfast with water |
| Comparator Agent |
Placebo |
One capsule daily in the morning after breakfast with water |
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. 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/m2.
2. Subjects with hand-grip strength will be greater than 28 kg for men and greater than 18 kg for women; (AWGS, 2019).
3. Subjects who score above 9 in the SPPB (Short Physical Performance Battery) tests.
4. Subjects agreed to get assessed for physical activity using (Global Physical Activity Questionnaire) GPAQ.
5. Subjects willing to participate in warming up followed by brisk walking exercise (5 days a week, 30 min per day) over study duration.
6. Subjects with clinical lab observations within normal range or considered not clinically significant by the principal investigator.
7. Subject willing to provide written informed consent and agree to be available for regular follow up throughout the study duration.
8. Subjects who are not nutritionally deprived or malnourished assessed using MNA-SF.
9. Willing to keep dietary records to allow macronutrient intake to be calculated during the study period. |
|
| ExclusionCriteria |
| Details |
1. Subjects having allergy or hypersensitivity to any of the ingredients in the investigational products.
2. Subjects with any pre-existing medical conditions which in the opinion of the investigator makes the subject unsuitable for inclusion.
3. Subjects underwent treatment for COVID-19 or tested positive during the study will be excluded.
4. Subjects who are receiving treatment for serious diseases (e.g., cardiovascular, immunological, respiratory, hepatobiliary, renal, neurological, musculoskeletal, mental, and infectious diseases, or malignant tumor).
5. 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.
6. Serious musculoskeletal abnormalities or damage to the lower extremities.
7. History of cancer within 5 years or are currently being treated (except for skin tumors other than melanoma).
8. Use of functional food or supplement for muscle strength improvement within prior two weeks.
9. Subjects who participated in resistance exercise within three months prior to the first/screening visit.
10. Subjects who participated in other interventional clinical trial in past three months.
11. Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
12. 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).
13. Subjects with diabetes (FBS greater than or equal to 126 mg/dL), hypertension (Systolic greater than 140 and Diastolic greater than 90 mmHg).
14. Subjects with COPD, asthma, any respiratory or breathing related disorders.
15. Subjects consuming excessive amounts of alcohol (more than 5 drinks per week) and smoking more than 5 cigarettes per day within three months.
16. 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.
17. Subjects under medications including anti-hypertensives, inhaled beta agonists, anti-hyperlipidemics, psychotropic etc.
18. Confirmed rheumatoid arthritis or other systemic autoimmune disease requiring immunosuppressive therapy or corticosteroids.
19. 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.
20. Subjects with HIV positive or any other STDs.
21. Subjects who are inappropriate per investigator. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change from baseline to end of the study in Quadriceps strength using (1RM) using leg extension exercise |
Week 0 (Baseline), Week 2, Week 4, Week 8, Week 12 and Week 16. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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. |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |