Health Condition 1: R54- Age-related physical debility Health Condition 2: M959- Acquired deformity of musculoskeletal system, unspecified Health Condition 3: M858- Other specified disorders of bonedensity and structure
Conditions
Interventions
Intervention1: Shatavari root extract Capsule 150mg: Microcrystalline cellulose, Shatavari root Extract, Piperine, Quercetin, Naringin, Silicon Dioxide
Dosage: One capsule once daily orally after brea
Sponsors
Ennature Biopharma, A unit of India Glycols Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Both male and female participants aged fifty years to seventy five years. 2.Participants with all of the following: a. SARC F questionnaire score of four or greater. b. Low grip strength defined as less than twenty seven kilograms for men and less than sixteen kilograms for women. c. Low Appendicular Skeletal Muscle defined as the sum of the lean soft tissue masses of the arms and legs, with values less than twenty kilograms for men and less than fifteen kilograms for women, or low Appendicular Skeletal Muscle adjusted for height squared with values less than seven point zero kilograms per square metre for men and less than five point five kilograms per square metre for women, measured using the Body Composition Monitor CULT. 3.Participants with osteopenia, defined as a spine T score between minus one and minus two point five on Dual Energy X ray Absorptiometry. 4.Women who have been postmenopausal for more than one year, defined as a minimum duration of one year between the last menstrual period and study entry. 5.Liver Function Test, Renal Function Test, Complete Blood Count, Electrocardiogram, lipid profile, and routine urine analysis values within normal limits, as determined by the investigator. 6.Glycated haemoglobin of eight percent or less and blood pressure of one hundred forty over ninety millimetres of mercury or less. 7.Women with menopausal symptoms having a modified Kupperman Index score in the moderate category, defined as a score of twenty or greater. 8.Female participants with Follicle Stimulating Hormone greater than thirty milli international units per millilitre and estradiol less than thirty picograms per millilitre. 9.Male participants with free testosterone less than twelve nanograms per decilitre. 10.Participants who are able to understand written and or verbal instructions, are willing to comply with all study requirements, and voluntarily provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.Contraindication to DEXA 2.Consumption of functional food or supplement that modifies body composition, during or 6 months prior to the study. 3.Who are under or planning or had hormonal therapy in the last 6 months. 4.Participants with osteoporosis and severe muscle disorders or damage 5.History of any cancer. 6.History of metabolic disorders, cardiac and psychiatric disorders 7.Clinical study participation in the last 90 Days. 8.Condition that in opinion of the investigator, does not justify the participants participation in the study. 9.Any surgery in the last 3 months. 10.Participants who have undergone hysterectomy 11.Participants taking any type of health supplements will be excluded from the study. If required, supplement intake within the allowable limit may be permitted at the investigator discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in SARC-F questionnaire 2.Change in Functional assessment - Hand grip & Gait speed test Timepoint: Screening, Baseline, Week 6, Week 8, Week 12, Week 16, Week 20, Week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in DEXA parameters - bone mineral density, BMD, T-score of Lumbar Spine 2. Change in muscle quantity - Appendicular Skeletal Muscle Mass using body composition monitor 3.Change in Bone specific alkaline phosphatase 4.Change in Myostatin levels 5.Change in SF-36 QoL questionnaire 6.Participant and physician global assessment 7.FSH, Estradiol female and Free testosterone male assessment Timepoint: Screening, Baseline, Week 6, Week 8, Week 12, Week 16, Week 20, Week 24. | — |
Countries
India
Contacts
Public ContactDr Gayathri Sivakumar
KI3 PRIVATE LIMITED
Outcome results
None listed