| CTRI Number |
CTRI/2024/05/067877 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Zincovit ACTIVE Instant Rehydration Solution in fatigue and stress |
|
Scientific Title of Study
|
A Prospective Comparative Placebo controlled clinical study to evaluate the efficacy and safety of Zincovit ACTIVE Instant Rehydration Solution in Fatigue/Stress |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Zincovit IRS/04/24 Ver 1.0 dated 01.05.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinoth |
| Designation |
Associate Professor, Department of General Surgery |
| Affiliation |
Mahatma Gandhi Medical College & Research Institute |
| Address |
Room no. 4, Dept. of General Surgery, Mahatma Gandhi Medical College & Research Institute, Pondy-Cuddalore Main Road,
Pillayarkuppam, Pondicherry -607 402
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9443667373 |
| Fax |
|
| Email |
drvino84@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Sakthi Balan |
| Designation |
Consultant and CI |
| Affiliation |
Ki3 Private Limited |
| Address |
Room 1, Medicine OPD, Thirumalai Medical Centre, Cuddalore main road, Pondicherry
PONDICHERRY
605004
India
Pondicherry
PONDICHERRY
605004
India |
| Phone |
9443627722 |
| Fax |
|
| Email |
saheerose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gayathri Sivakumar |
| Designation |
Director |
| Affiliation |
Ki3 Private Limited |
| Address |
Regus Centre Level 2 Altius Block No 1 SIDCO Industrial Estate Chennai
Chennai
TAMIL NADU
600032
India
Chennai
TAMIL NADU
600032
India |
| Phone |
9003109416 |
| Fax |
|
| Email |
venkat_ani2007@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Apex Laboratories Private Limited, 3rd Floor , SIDCO Garment Complex, SIDCO Industrial Estate, Guindy, Chennai 600032 |
|
|
Primary Sponsor
|
| Name |
Apex Laboratories Private Limited |
| Address |
3rd Floor , SIDCO Garment Complex, SIDCO Industrial Estate, Guindy, Chennai 600032 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr M Venkatram |
East Coast Hospitals |
No 1, Paris Nagar, Moolakulam, Puducherry, 605010
Pondicherry
PONDICHERRY |
9042846842
brvenkatram@gmail.com |
| Dr Vinoth |
Mahatma Gandhi Medical College & Research Institute |
Room no. 4, Department of General surgery, Mahatma Gandhi Medical College & Research Institute, Pondy-Cuddalore Main Road,
Pillayarkuppam, Pondich erry -607 402
Pondicherry
PONDICHERRY |
9443667373
drvino84@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| ETHIQUE DE LA NATURE ASSOCIATION |
Approved |
| ETHIQUE DE LA NATURE ASSOCIATION |
Approved |
| Mahatma Gandhi Medical College and Research Institute- Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R538||Other malaise and fatigue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo oral solution |
Sucrose Solution
taken orally (200 ml) twice daily for 7 days |
| Intervention |
Zincovit ACTIVE Instant Rehydration Solution |
Zinc 1 mg, Potassium chloride 0.157 mg, Sodium citrate 0.294 mg, Magnesium 10 mg, Calcium 15 mg , Taurine 80 mg in Apple flavour/ Orange flavour
Taken orally (200 ml)twice daily for 5-7 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Subjects, aged 18 years and above.
2) Subjects suffering from fatigue due to fever, post operative period, dehydration and
tiredness after excessive physical activity.
3) Measurable fatigue, defined as a score of ≥ 10 on the fatigue severity scale |
|
| ExclusionCriteria |
| Details |
1) Severe dehydration and/or use of IV fluids for current hospitalization
2) Experiencing bloody diarrhea or diarrhea due to cholera, dysentery,
persistent/chronic diarrhea, diarrhea with severe malnutrition, diarrhea associated
with recent antibiotic use
3) In the opinion of the investigator, not suitable for treatment with IRS
4)
Have any underlying disease or disorder that may, in the opinion of the investigator,
affect the results of the study if they were enrolled (includes, but is not limited to,
renal disease, gastrointestinal disorders such as Crohn's disease or other
inflammatory bowel disease or congenital malabsorption disorders)
5)Known to be allergic to any of the components of the investigational product
6)Pregnant or lactating Women
7)Uncontrolled type 2 Diabetes mellitus (HbA1c>10).
8)A history of neurological or psychiatric diseases
9)Alcohol or substance abuse
10)Subjects taking any nutritional supplements.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Acute treatment effects on subjective arousal/stress/fatigue ratings as assessed by visual analogue scales during follow ups
2. Subjective ratings of arousal (concentration, mental stamina/physical stamina) stress and fatigue (mentally tired/physically tired) visual analogue scales
3. Changes in the electrolyte levels
4. Reduction in overall fatigue as measured by Fatigue Severity Scale
5. Convalescence time and cognitive assessment will be done
6. Study IRS intake |
Baseline, 24 hrs, 48 hrs and 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Study Subject & investigator feedbacks & quality of life will be assessed
2. Medically confirmed adverse events collected throughout the study period
3. Record study subject use of antibiotics & other drugs during hospitalization |
Baseline, 24 hrs, 48 hrs & 7 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study will include 80 study subjects suffering from fatigue due to fever, dehydration and tiredness after excessive physical activity or during surgery post OP care, will be recruited and screened as per the inclusion criteria.
Primary end Points
1) Acute treatment effects on subjective arousal/ stress/ fatigue ratings as assessed by visual analogue scales during follow ups (Time frame: 0 min, 15 min, 30 min, 1 hr, 2 hr, 6hr, 12 hr, 24 hr and 48 hr and post study)
2) Subjective ratings of arousal (0 min, 15 min, 30 min, 1 hr, 2hr, 6hr, 12 hr, 24hr and 48 hr and post study)
3) Changes in the electrolyte levels 4) Reduction in overall fatigue as measure by Fatigue Severity scale 5) Convalescence time will be monitored 6) Study Subjective cognitivr assessment will be monitored ((pre and post study)
7) Clinical Assessment of study subjects hydration status based on presenting symptoms
8) Study IRS intake 9) Study Subject Satisfaction questionnaire
Secondary Outcomes
1) Study Subjects and Investigator feedbacks and quality of life 2) Medically confirmed adverse events collected throughout the period 3) Record study subject use of antibiotics and other drugs 4) Safety and tolerability evaluation criteria
|