| CTRI Number |
CTRI/2018/05/014174 [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 test whether study drug could
decrease damage from oxidative stress and inflammation related to acute muscle injury
induced by eccentric continuous exercise. |
|
Scientific Title of Study
|
A randomised, placebo-controlled, double blind clinical trial to test whether study drug could
decrease damage from oxidative stress and inflammation related to acute muscle injury
induced by eccentric continuous exercise. |
| Trial Acronym |
DOMS study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BIAG-CSP-007 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anand B B |
| Designation |
Consultant |
| Affiliation |
Raja Lakshmi Hospital |
| Address |
Raja Lakshmi Hospital
No. 21/1, Lakshmipura main road Vidhyaranyapura post, Bangalore
Raja Lakshmi Hospital
No. 21/1, Lakshmipura main road Vidhyaranyapura post, Bangalore
Bangalore
KARNATAKA
560097
India |
| Phone |
919448034602 |
| Fax |
|
| Email |
anandabb007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shalini Dayananda |
| Designation |
General Manager |
| Affiliation |
BioAgile Therapeutics Pvt Ltd |
| Address |
#2/5, Dahlia Building, 3rd Floor,
80 Feet Road, RMV 2nd Stage,
Bangalore
#2/5, Dahlia 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 |
Divya C |
| Designation |
Director |
| Affiliation |
BioAgile Therapeutics Pvt Ltd |
| Address |
#2/5, Dahlia Building, 3rd Floor,
80 Feet Road, RMV 2nd Stage,
Bangalore
#2/5, Dahlia 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
|
|
|
Primary Sponsor
|
| Name |
Plant Lipids P limited |
| Address |
Plant Lipids (P) Limited Kolenchery, Cochin - 682 311, Kerala, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
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 |
| Raja Lakshmi Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Delayed Onset Muscle Soreness (DOMS) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cureit |
500mg capsule once daily |
| Comparator Agent |
Placebo |
Capsule 500mg once daily |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: more than 20 years
2. Subjects will be healthy, moderately active (regular aerobic exercise for at least 4 hours per week), non-smoking volunteers with no known musculoskeletal pathology.
3. Subjects should have a maximal oxygen consumption (VO2max) of at least 35 ml/kg, as assessed by the maximal treadmill exercise test.
4. 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 efficacy of herbal preparation in patients with Delayed onset muscle soreness (DOMS) due to eccentric muscle activity.
|
Screening visit - day-7 day1 day2 day3 and day4
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the safety of herbal preparation in patients with Delayed onset muscle soreness (DOMS) due to eccentric muscle activity.
|
Screening visit - day-7 day1 day2 day3 and day4 |
|
|
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) |
08/08/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="30" |
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
|
Delayed onset muscle soreness (DOMS) is a familiar experience for the elite or novice athlete. Symptoms can range from muscle tenderness to severe debilitating pain. The mechanisms, treatment strategies, and impact on athletic performance remain uncertain, despite the high incidence of DOMS. DOMS is most prevalent at the beginning of the sporting season when athletes are returning to training following a period of reduced activity. DOMS is also common when athletes are first introduced to certain types of activities regardless of the time of year. This problem can be trounced by innovative Curcumin preparation. It has been inferred that the test compound shows a concentration dependent DPPH free radical scavenging activity indicating its antioxidant potential equivalent to ascorbic acid. Based on the result in the study, it was concluded that the bio available curcumin-“cureit†could be a good source of natural antioxidant. |