| CTRI Number |
CTRI/2024/10/074932 [Registered on: 08/10/2024] Trial Registered Prospectively |
| Last Modified On: |
02/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study to Test the Safety and Effects of Neuherbs Deep-Sea Fish Oil Compared to an Inactive Supplement in Adults. |
|
Scientific Title of Study
|
A Randomized, Prospective, Double-Blinded, Comparative Clinical Study to Evaluate the Safety and Efficacy of the Neuherbs Deep-sea Fish oil Compared with Placebo in Adults. |
| Trial Acronym |
Nil |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CTSRS/2406 Version No. 2.0 Dated 05/Aug/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manjunath U |
| Designation |
Principal Investigator |
| Affiliation |
Good Life hospital |
| Address |
No 55 56, Bhoo Samartha Layout, K.S Halli, Seegehalli Road
Bangalore
KARNATAKA
560069
India |
| Phone |
6364898825 |
| Fax |
|
| Email |
udrmanjunath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Sathyavathi L M |
| Designation |
HOD-Clinical Operations and QA |
| Affiliation |
Samahitha Research Solutions |
| Address |
No.1204, Ashva, 2nd Floor,
26th Main, Jayanagar 9th Block
Bangalore
KARNATAKA
560069
India |
| Phone |
9739001749 |
| Fax |
|
| Email |
satyalm@samahitha.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Arpita Malgi |
| Designation |
Team-Lead Clinical Operations |
| Affiliation |
Samahitha Research Solutions |
| Address |
No.1204, Ashva, 2nd Floor,
26th Main, Jayanagar 9th Block
Bangalore
KARNATAKA
560069
India |
| Phone |
6364898825 |
| Fax |
|
| Email |
arpita@samahitha.com |
|
|
Source of Monetary or Material Support
|
| Global Healthfit Retail India LLP under the brand name Neuherbs Plot No.208, Block Udyog Kendra Extension-II, Sector Ecotech-III, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh- 201306, India. |
|
|
Primary Sponsor
|
| Name |
Global Healthfit Retail India LLP under the brand name Neuherbs |
| Address |
Plot No.208, Block Udyog Kendra Extension-II,
Sector Ecotech-III,
Greater Noida,
Gautam Buddha Nagar,
Uttar Pradesh- 201306, 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 Manjunath U |
Good Life Hospital |
No 55 56, Bhoo Samartha Layout, K.S Halli, Seegehalli Road
Bangalore
KARNATAKA |
6364898825
udrmanjunath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PRANAV DIABETES CENTER ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E789||Disorder of lipoprotein metabolism, unspecified. Ayurveda Condition: MEDOROGAH, (2) ICD-10 Condition:D899||Disorder involving the immune mechanism, unspecified. Ayurveda Condition: SOPA-UPADRAVAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Neuherbs Deep-sea Fish oil, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -1 capsule twice a day after food for 90 days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Placebo, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -1 capsule twice a day after food for 90 days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of both sexes aged between 30 to 65 yrs.
2.BMI ranging from 25 to 30 Kg per m2
3.LDL Cholesterol level 1.3g per liter to 1.89g per liter
|
|
| ExclusionCriteria |
| Details |
1.Pregnant or lactating women.
2.Patients currently taking lipid lowering drugs (including statins, fibrates.
3.Patients with high serum triglycerides (defined by more than 250 mg per dL)
4.Patients with any neoplastic, cardiovascular disorder or other concurrent medical illness (malabsorptive disorders, acute and chronic inflammation) confirmed based on medical history, physical examination and recent routine laboratory tests such as CBC and Urinalysis.
5.Patients with known history of hypersensitivity to the study drugs.
6.Alcoholic consumers and smokers
7.Currently or has been taking an investigational drug in the past 30 days. |
|
|
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 |
1.Reduction in hsCRP levels between the two treatment arms at day 60 and day 90 of intervention
2.Reduction in Lipid Profile values between the two treatment arms at day 60 and day 90 of intervention
|
Day 0, 30, 60 and 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change in BMI and body weight between the two treatment arms at day 60 and day 90 of intervention
2.Adverse events and relevant abnormal laboratory findings (serious/non-serious, expected/unexpected, related/non-related) between the two treatment arms
3.Percentage of patients with adverse events between the two treatment arms
4.Treatment discontinuation rates: Early discontinuation, discontinuation due to adverse events between the two treatment arms. |
Day 0, 30, 60 and 90 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
14/10/2024 |
| Date of Study Completion (India) |
22/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Overall Study Conclusion neuherbs Deep Sea Fish Oil demonstrated significant efficacy and an excellent safety profile compared with placebo over 90 days. The intervention significantly reduced systemic inflammation, as evidenced by reductions in hsCRP of minus 0.496 plus or minus 0.15 mg/L at Day 60 (p = 0.0008) and minus 0.65 plus or minus 0.24 mg/L at Day 90 (p = 0.00000129). Significant improvements in lipid parameters were also observed, including reductions in LDL cholesterol by minus 20.15 mg/dL (p less than 0.0001) and triglycerides by minus 17.44 mg/dL (p less than 0.0001), along with an increase in HDL cholesterol by plus 8.84 mg/dL (p less than 0.0001) at Day 90. Furthermore, BMI decreased significantly by minus 1.68 plus or minus 0.54 kg/m2 at Day 60 (p less than 0.0001) and minus 2.36 plus or minus 0.52 kg/m2 at Day 90 (p less than 0.0001), supporting potential weight management benefits. No adverse events, abnormal laboratory findings, serious adverse events, or treatment discontinuations were reported, and all randomized subjects completed the study. Collectively, these findings indicate that neuherbs Deep Sea Fish Oil is a safe, well tolerated intervention that provides meaningful anti inflammatory, cardiometabolic, and weight management benefits. |