None listed
Conditions
Interventions
Intervention1: HNH13_16: 400 mg capsule, oral route of administration, two capsules twice a day(lunch and dinner) 15 mins before meal with drinking water, consume for 30 days
Control Intervention1: Pl
Sponsors
Advanced Enzymes Technologies Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy Male and or female one is to one ratio 60 plus years old established age related joint inflammation 2. Medically deemed fit by a physician 3. Average VAS fatigue score greater than or equal to 4 after completing a 6 min walk test at maximum speed followed by a 30 sec chair test without rest in between for 7 consecutive days prior to baseline 4. Able to perform all the physical tests mentioned in the study
Exclusion criteria
Exclusion criteria: 1. History of consumption of dietary supplements within two weeks prior to screening 2. Subjects who have had joint surgery within the last 6 months 3. Known case of hypersensitivity to the study product 4. Known case of any musculoskeletal disorder 5. History/presence of acute or chronic disease or uncontrolled comorbidities of cardiac liver kidney etc such as severe/uncontrolled hypertension or heart condition unstable heart failure chronic kidney disease or liver damage requiring treatment in the opinion of the investigator which would jeopardize the study outcome 6. Females who are breastfeeding/pregnant or intend to become pregnant during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the change in Physical function with respect to maximum handgrip strength test, knee muscle strength and power, functional performance tests including 6 min walk test, 30 s chair stand test, 3 m timed up and go test, arm curl test, and chair sit and reachTimepoint: Day 1 and Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| i. Change in Visual Analogue Scale VAS score for Fatigue from pre to post 6 min walk test plus 30 sec chair test ii. Change in markers of fatigue, inflammation, & oxidative stress a. Change in Blood Lactate Concentration from pre to 10 min post 6 min walk test plus 30 sec chair test b. Change in High sensitivity CRP hs CRP, thiobarbituric acid reactive substances TBARS i.e. malondialdehyde MDA iii. Change in Physiological response a. Changes in SPO2 levels, Body temperature, & Blood pressure SBP & DBP from pre to immediately post 6 min walk test plus b. 30 sec chair test iv. Change in CIS Fatigue Scale scores v. Change in Pain, Enjoyment, General Activity PEG scale scores Timepoint: Screening, Day 1, 30 & 40;vi. Change in Quality of life score WHO 5 Well Being Index 5 items vii. NSAIDs sparing effect a. Change in the number of days frequency per week of NSAID consumption b. Discontinuation Rate Number of participants who stop NSAID use entirely during the study period viii. Changes in Anthropometric parameters Body weight, waist circumference, BMI ix. Changes in Hematological & biochemical parameters a. Hematological Serum haemoglobin, Complete & differential blood count, platelets b. Biochemical Serum Glutamic Oxaloacetic Transaminase SGOT, Serum Glutamic Pyruvic Transaminase SGPT, serum creatinine, blood urea nitrogen BUN, random blood sugar RBS, total cholesterol, & total albumin & globulinTimepoint: Screening, day 1, day 30 & day 40;x. Changes in Vital signs & Physical examination a. Vital Signs Hypertension systolic blood pressure, SBP, diastolic blood pressure, DBP, pulse rate, respiration rate, & body temperature b. Physical Examination Include examination of but not be limited to general appearance, head & neck, cardiovascular system, respiratory system, gastrointestinal system, & nervous system, etc. xi. Assessment of Tolerability Adverse events AEs or serious adverse events SAEsTimepoint: Day 1 & day 30 | — |
Countries
India
Contacts
Public ContactPratik Shah
Advanced Enzymes Technologies Limited
Outcome results
None listed