| CTRI Number |
CTRI/2023/12/060512 [Registered on: 18/12/2023] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To evaluate the benefits and side effects of garlic extract in the patients with mild hypertension who are under standard care of treatment. |
|
Scientific Title of Study
|
A randomized double blinded placebo controlled clinical study to evaluate
the efficacy and safety of S allylcysteine as an adjuvant treatment in patients
with Grade 1 Grade 2 hypertension |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjana Kumari V T |
| Designation |
Principal Investigator |
| Affiliation |
Sri Laxmi Hospital |
| Address |
Sri Laxmi Hospital 50 Opp to Velankani road Doddathogur Village Electronics City Bangalore
Bangalore
KARNATAKA
560100
India |
| Phone |
9483727956 |
| Fax |
|
| Email |
dr.sanjanalaxmi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Satish G |
| Designation |
Vice President Clinical Research |
| Affiliation |
Sami Sabinsa Group Limited |
| Address |
Sami Sabinsa Group Limited
19 1 19 2 I Main II Phase Peenya Industrial Area
Bangalore 560 058 Karnataka India
Bangalore
KARNATAKA
560058
India |
| Phone |
9900128263 |
| Fax |
|
| Email |
satish.g@sami-sabinsagroup.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Satish G |
| Designation |
Vice President Clinical Research |
| Affiliation |
Sami Sabinsa Group Limited |
| Address |
Sami Sabinsa Group Limited
19 1 19 2 I Main II Phase Peenya Industrial Area
Bangalore 560 058 Karnataka India
Bangalore
KARNATAKA
560058
India |
| Phone |
9900128263 |
| Fax |
|
| Email |
satish.g@sami-sabinsagroup.com |
|
|
Source of Monetary or Material Support
|
| Sami Sabinsa Group Limited
19 1 and 19 2 I Main II Phase Peenya Industrial Area Bangalore |
|
|
Primary Sponsor
|
| Name |
Sami Sabinsa Group Limited |
| Address |
19 1 and 19 2 I Main II Phase Peenya Industrial Area
Bangalore 560 058 Karnataka India |
| Type of Sponsor |
Other [Manufactures and markets phytonutrients standardized herbal extracts and nutritional supplements] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shivaprasad |
JSS Ayurveda Medical College and Hospital |
#41/E, Lalithadripura Road, Mysuru Karnataka- 570028
Mysore
KARNATAKA |
9741160800
shivaprasadhuded@yahoo.com |
| Dr Sanjana Kumari VT |
Sri Laxmi Hospital |
50 Opp to Velankani road Doddathogur Village
Electronics City Bangalore 560100
Bangalore
KARNATAKA |
9483727956
dr.sanjanalaxmi@gmail.com |
| DrKiran Kumar Macherla |
StTheresasHospital |
Sanathnagar,Hydrabad.Telangana-500018,India
Hyderabad
TELANGANA |
8008220098
kiran.macherla@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| ACE Independent Ethics Committee |
Approved |
| EthicsCommitteeStTheresas Hospital |
Approved |
| Institutional ethics committeeJSSmedical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aged garlic extract |
200 mg capsule [Aged garlic extract containing 1-1.5 mg S allyl cysteine] once a day after dinner for 90 days |
| Comparator Agent |
Microcrystalline cellulose |
200 mg capsule containing microcrystalline cellulose, once a day after dinner for 90 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Male and Female participants whose age ≥ 18 and ≤ 60 years
2 Participants must provide a written and signed informed consent and comply with requirements of the study
3 Must be able to swallow oral medications for 90 days daily and comply with the study requirements as per the protocol
4 Known case of Grade 1 / Grade 2 hypertension (Systolic BP 120-159mmHg & Diastolic BP 80 – 99mmHg) with the use of antihypertensive medication
5 Patients should be on monotherapy & with a mild dose of antihypertensive drug
6 Subjects who meet any of the two following criteria to be included in the study
1) Triglyceride > 150 to 200mg/dl
2) HDL cholesterol < 50 mg/dL (or 1 29 mmol/L) in women or < 40 mg/dL (or 1 04 mmol/L) in men
3) LDL cholesterol > 120 to 160 mg/dL
4) Serum Total Cholesterol > 200 to 250 mg/dL |
|
| ExclusionCriteria |
| Details |
1. Patients with more than one antihypertensive drugs.
2. Participants with secondary hypertension.
3. Participants with hypertensive crisis.
4. Patients with uncontrolled hypertension with medication.
5. Participants with HbA1c > 6.5%.
6. Intake of over the counter or prescribed Allopathic/Ayurvedic/
Homeopathic/Naturopathic medications.
7. History of chronic smoking (more than 2 cigarettes a day)
8. Alcoholics (Inability to control drinking due to both physical & emotional dependence
on alcohol characterized by uncontrolled drinking & preoccupation with alcohol).
9. Patients with evidence of malignancy.
10. Patients having history of coagulopathies, cardiovascular diseases, congestive heart
failure, pancreatitis, lactic acidosis, hepatomegaly with steatosis, motor weakness,
peripheral sensory neuropathy, psychiatric disorder, Severe Pulmonary Dysfunction
(uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease
[COPD].
11. History of severe psychiatric disorders like schizophrenia or bipolar disorder.
12. Patients on prolonged (> 4 weeks) medication with corticosteroids, antidepressants,
anticholinergics, etc. or any other drugs that may have an influence on the outcome of
the study.
13. Patients with concurrent serious hepatic disorder (defined as Aspartate Amino
Transferase (AST) and/or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline
Phosphatase (ALP)>2 times upper normal limit) or Renal Disorders (defined as S.
Creatinine>1.2mg/dL for females or >1.4 mg/dL for males and EGFR <60).
14. History of hypersensitivity to any of the herbal extracts or dietary supplement.
15. Pregnant/lactating women and those not willing to follow a reliable and effective
contraceptive measure during the study.
16. Those who have participated in any other clinical trial within three months from the
screening.
17. Any other condition which the Principal Investigator thinks may jeopardize the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Mean change in Systolic Blood Pressure & Diastolic Blood Pressure
2. Mean change in Pulse pressure |
1. Screening to Day 90
2. Screening to Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Mean change in Lipid profile
|
Screening to Day-90
|
Mean change in participants quality of life through WHO-BREF questionnaire
Safety is determined by the incidence of AE/SAE in both groups |
Randomization Day to Day-90 |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
29/12/2023 |
| Date of Study Completion (India) |
08/09/2025 |
| 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)
|
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)
|
This study involves 70 subjects randomized in two arms and will receive 90 days of treatment and telephonic follow up after seven days following the last visit. Participant will be randomized to receive 200 mg (aged garlic extract containing 1- 1.5 mg of SAC) [arm 1] or 200 mg of placebo (microcrystalline cellulose) [arm 2]. Mean change in pulse pressure and blood pressure will be measured. |