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CTRI Number  CTRI/2018/05/014176 [Registered on: 29/05/2018] Trial Registered Prospectively
Last Modified On: 29/11/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to evaluate the efficacy of the study drug supplementation in otherwise healthy elderly subjects in the management of Sarcopenia 
Scientific Title of Study   A randomised, placebo-controlled, double blind clinical trial to evaluate the efficacy of the study drug supplementation in otherwise healthy elderly subjects in the management of Sarcopenia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
BAIG-CSP-008   Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anand BB 
Designation  Consultant 
Affiliation  Rajalakshmi Hospital 
Address  Rajalakshmi Hospital, #21/1, Lakshmipura main road (opp. Lashmipura lake) vidhyaranyapura post, Bangalore

Bangalore
KARNATAKA
560097
India 
Phone  9620438767  
Fax    
Email  anandabb007@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mrs Shalini Dayananda 
Designation  General Manager 
Affiliation  BioAgile Therapeutics Pvt. Ltd 
Address  # 2/5, Dahila building, 3rd floor, 80 feet road, RMV 2nd stage, Bangalore

Bangalore
KARNATAKA
560094
India 
Phone  9980107723  
Fax    
Email  pm@bioagiletherapeutics.com  
 
Details of Contact Person
Public Query  
Name  Mrs Divya C 
Designation  Director 
Affiliation  BioAgile Therapeutics Pvt. Ltd 
Address  # 2/5, Dahila building, 3rd floor, 80 feet road, RMV 2nd stage, Bangalore

Bangalore
KARNATAKA
560094
India 
Phone  9538961761  
Fax    
Email  divya@bioagiletherapeutics.com  
 
Source of Monetary or Material Support  
Funding Agency 
 
Primary Sponsor  
Name  Plantlipids P LTD 
Address  Plantlipids (P) Limited Kolenchery, Cochin-682311 Kerala, India. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anand B B  RajaLakshmi Hospital  No. 21/1, Lakshmi pura main road (opp. Lakshmipura lake), Vidhyaranyapura post, Bangalore-560097
Bangalore
KARNATAKA 		 9448034602

anandabb007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rajalakshmi Hospital Institutional Ethics Committee(RHIEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Subjects with apparent loss of strength and tiredness 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cureit capsule   500mg 
Comparator Agent  Placebo   Capsule 500 mg once daily 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. 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  
 
ExclusionCriteria 
Details  1. 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.
3. 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.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the safety of herbal preparation in the management of sarcopenia  Day1 Day90 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the efficacy of herbal preparation in the management of sarcopenia  Day1 Day90 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/05/2018 
Date of Study Completion (India) 26/11/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  		 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. 
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