A clinical trial to evaluate the efficacy of the study drug supplementation in otherwise healthy elderly subjects in the management of Sarcopenia

Completed

Brief Summary: Sarcopenia represents a major clinical issue, given also the increasing prevalence of elderly people in the general population. This clinical condition can lead to a number of health problems, with a significant burden to the healthcare system. It has been proposed that nutritional supplementation can have a role in the prevention and management of sarcopenia. Curcumin has a poor systemic bioavailability. Several attempts have been made to overcome this limitation: in particular, dispersion of active molecules (typically belonging to the chemical class of polyphenols and triterpenes) with phospholipids under appropriate conditions leads to the formation of a delivery form. Among these complexes, the commercially available curcumin has been studied for the treatment of a wide range of conditions compared versus non-formulated Curcumin. On these bases, curcumin may represent a potential nutritional intervention to control sarcopenia in affected subjects, in particular for elderly. Thus, this study is aimed to evaluate the effects of study drug supplementation in otherwise healthy elderly subjects, in order to preliminarily evaluate its efficacy in the management of sarcopenia.

Recruitment & Eligibility

Inclusion Criteria

Age: more than 65 years 2.
Subjects will be apparently healthy with 3.
Subjects willing to sign an informed consent and adhere to all protocol requirements.

Exclusion Criteria

Treatment with anti-inflammatory/analgesic/antioxidant drugs in the previous month 2.
Abnormal liver or renal function tests, laboratory findings suggestive of an active inflammatory or infectious process and presence of any known disease.
Pregnancy or breast feeding 4.
Current alcoholism or drug abuse 5.
Allergies to one of the component substances in the trial 6.
Medication (active medication) 7.
Participation in another clinical trial less than 3 months previously.

Primary Outcome Measures

Name	Time	Method
To assess the safety of herbal preparation in the management of sarcopenia	Day1 Day90

Secondary Outcome Measures

Name	Time	Method
To assess the efficacy of herbal preparation in the management of sarcopenia	Day1 Day90

Locations (1): RajaLakshmi Hospital
🇮🇳
Bangalore, KARNATAKA, India
RajaLakshmi Hospital
🇮🇳Bangalore, KARNATAKA, India
Dr Anand B B
Principal investigator
9448034602
anandabb007@gmail.com