None listed
Conditions
Interventions
Intervention1: CL22209 - 50 mg: One capsule to be consumed with water after breakfast for 12 Weeks
Control Intervention1: Placebo: One capsule to be consumed with water after breakfast for 12 Weeks
Sponsors
Aditya Research Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy working women aged 25 to 40 years, with a BMI of 21 to 28 kg/m2, with a score of more or equal 27 on Fatigue Severity Scale (FSS). 2.Subjects with self-reported sleep complaints. 3. Sufficient language skills, readiness, and ability to comply with the physicians instructions, ton respond to all interview questions and to fill in the self assessment scales without evident difficulties and without assistance of an interpreter. 4. Subjects of childbearing potential must be using a medically acceptable form of birth control. 5. Results of screening and laboratory investigations are within the normal range or considered not clinically significant by the prinicipal investigator (PI). 6. Agree to participate in the study through a written informed consent form. 7.willing to comply with all the study related activities. 8. Has not taken any type of medicine or herbal supplements in the past 3 months related to stiudy indication. 9. Subjects free from terminal illnesses such as cancer. 10. ECG without clinically significant abnormalities. 11.Subjects with general cognition and functional performance sufficiently preserved such that a diagnosis of Alzheimers disease cannot be made by the site physician at the time of the screening vist.
Exclusion criteria
Exclusion criteria: 1. Subjects working in rotational shifts. 2. subjects with signs of depression as per the discretion of PI. 3. subjcets with history of major depression or another major psychiatric disorder with in the past 6 months. 4. any significant neurologic disease, such as parkinsons disease, stroke, TIAs, multiinfract dementia, Huntingtons disease, head trauma, chronic CNS infection. Subjects diagnosed with sleep apnea or related disorders. 5.Any clinically significant hepatic, renal, cardiovascular, pulmonary, gastrointestinal or haematological illness or unstable medical condition which could interfere with investigational supplement safety, or absorption, distribution, metabolism and excretion,or lead to difficulty complying with the protocol. 6. Subjects with fasting blood glucose levels more than 125 mgdl and blood pressure (Systolic more than or equal 140 mmHg and Diastolic more than or equal 90 mmHg). 7. Alcoholics and Smokers. 8. Clinically significant obstructive pulmonary disease or asthma. 9. Clinically significant liver disease, coagulopathy or vitamin K deficiency within the past two years prior to screening. 10.History of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities. 11. History of alcohol or substance abuse or dependence within the past year. 12. Subjects with HIV Positive. 13. Indication of inability to make decisions regarding study participation. 14. Disability that may prevent the subject from completing all study requirements (e.g. blindness, deafness, severe language difficulty, etc.). 15. Women who are pregnant, lactating or planning to become pregnant during the study period. 16. Enrolment in another investigational study or intake of investigational drug within the previous three months. 17. Suspected or known allergy to any components of the study supplement. 18. Any condition which in the opinion of the investigator makes the patient unsuitable for inclusion. 19.Subjects who enjoy high-intensity exercise leading to fatigue.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scores of Fatigue Severity Scale (FSS)Timepoint: Visit 1, 2, 3, and 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Scores of the Athens Insomnia Scale (AIS). 2. Scores of Physical & mental fatigue, Speed of thinking, Healing of tiredness, concentration, motivation, lightness of body, mood, calmness, and awakening on a 10 cm visual analogue scale (VAS) 3. Scores of Burnout Assessment Tool (BAT) 4. Scores of Perceived stress scale (PSS-10) 5. Scores of Profiles of mood states- Short Form (POMS-SF) 6. Adverse events (AEs), frequency, and severity. 6. Number of subjects who discontinue study due to adverse events. 7. Haematology, vital signs and clinical biochemistry parameters. Timepoint: 1. Visit 2, 3, and 4. 2. Visit 2, 3, and 4. 3. Visit 2, 3, and 4. 4. Visit 2, 3, and 4. 5. Visit 2, 3, and 4. 6. Visit 1, 2, 3, and 4. 7. visit 1 and 4 | — |
Countries
India
Contacts
Public ContactDr CH Arun Kumar
Aditya Multispeciality Hospital
Outcome results
None listed