Health Condition 1: R531- Weakness Health Condition 2: R531- Weakness
Conditions
Interventions
None listed
Sponsors
Kerala Ayurveda Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 18 to 60 years 2. Both male and female 3. Subject meet criteria for fatigue as per Chalder Fatigue Assessment scale. 4. Subjects willing and able to provide informed consent voluntarily 5. Patient is willing and able to comply with all trial requirements
Exclusion criteria
Exclusion criteria: 1. Pregnant or Breast feeding. 2. Inability to provide voluntary consent. 3. Volunteers who have participated in any drug research study within past 3 months 4. Patients with pre existing severe systemic disease like uncontrolled diabetes, hypertension, and Cardiac illness etc necessitating long term medication. 5. Evidence of significant uncontrolled co morbid disease which in the investigators opinion would jeopardize patient participation. 6. Any clinically significant medical history, medical finding or an ongoing medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol. 7. History of cancer, including solid tumors, hematologic malignancies and carcinoma in situ 8. Use of any anti psychotic drugs in the past. 9. Subjects who abuse drugs or alcohol 10. Use of any investigational medication within 4 weeks prior to start of study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.% Improvement in Chalder Fatigue Scale (CFQ 11) (Time points: Baseline, Day 7, Day 14, Day 28) 2.% Improvement in energy/fatigue scale of the RAND-36 questionnaire. (Time points: Baseline, Day 7, Day 14, Day 28) Timepoint: Day 0day 7 ,Da 14 and Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of Total energy expenditure and Physical Activity (IPAQ Questionnaire)Timepoint: Baseline (Day 0) and Day 28 | — |
Countries
India
Contacts
Public ContactDrSarala Samuel
Kerala Ayurveda Ltd.
Outcome results
None listed