| CTRI Number |
CTRI/2020/04/024646 [Registered on: 15/04/2020] Trial Registered Prospectively |
| Last Modified On: |
03/04/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study on efficacy of herbal nutritional supplement in management of hypertension |
|
Scientific Title of Study
|
An Open-label, single center, Non – Interventional, Observational Study
to Evaluate Efficacy and safety of Herbal nutritional Supplement
(Cuminum cyminum, Zingiber officinale, Myristica fragrans, Elettaria
cardamomum, Linum usitatissimum, Psidium guajava ,Curcuma longa,
Cinnamomum verum, Syzygium aromaticum, Glycyrrhiza glabra,
Trigonella foenum-graecum, Foeniculum vulgare, Nigella sativa) in
management of hypertension and its associated risk factors |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Satyanarayana murthy |
| Designation |
Sr Diabetologist |
| Affiliation |
Vijaya Superspecialty Hospital |
| Address |
Diabetes endocrine clinic
A unit of Vijaya Superspecialty Hospital Research Projects
SPSR nellore District
AndhraPradesh
Nellore
ANDHRA PRADESH
524001
India |
| Phone |
|
| Fax |
|
| Email |
sln.uoh10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sadhu Lokanadham |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SANTHIRAM MEDICAL COLLEGE&HOSPITAL |
| Address |
Dr Sadhu Lokanadham
Associate Professor
Department of Anatomy
Santhiram Medical College
Nandyal
Kurnool
ANDHRA PRADESH
518501
India |
| Phone |
|
| Fax |
|
| Email |
loka.anatomy@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr C S Janaki |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Bharath University |
| Address |
Associate Professor
Department of Anatomy
Bharath Medical College
chennai
Chennai
TAMIL NADU
67044
India |
| Phone |
|
| Fax |
|
| Email |
drsadhuln.anatomy@gmail.com |
|
|
Source of Monetary or Material Support
|
| DIABLISS Pvt LIMITED
TIRUVANMIYUR
Chennai
Tamilnadu, INDIA.
|
|
|
Primary Sponsor
|
| Name |
DIABLISS PVT LIMITED |
| Address |
DiaBliss Consumer Products Pvt. Limited,
Thiruvanmiyur,
Chennai
Tamilnadu
India
Chennai, Tamilnadu, INDIA.
|
| Type of Sponsor |
Other [Conumer products Limited] |
|
|
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 Gayazuddin |
Vijaya superspeciality Hospital |
Diabetes & Endocrine Clinic
A unit of Vijay Super Speciality Hospital
Raghava Cine Complex
Poga thota
SPSR Nellore
Nellore
ANDHRA PRADESH |
8096368108
algaayes@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VIJAYA ETHICS COMMITTEE |
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 |
Diabliss Herbal Solution |
15 ml per day 15 ml of herbal nutritional supplement solution dissolved 1 Liter of water and Patients should take this1 Liter solution in a day: 150 ml just before & 150 ml just after breakfast, 150 ml just before & 150 ml just after lunch, 150 ml just before & 150 ml just after dinner and balance 100 ml at bed time for a period of 6 months. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Male and female treatment naïve patients, aged >45 years, with diagnosis of hypertension (DBP 110 mm Hg and SBP >150mm Hg) |
|
| ExclusionCriteria |
| Details |
Male and female treatment naïve patients, aged <45 years, with diagnosis of hypertension (
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| efficacy of suppliment in 60 days in hypertesive patients and its management with basic parameters |
30 days from the enrollment day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| efficacy of suppliment in 60 days in hypertesive patients and its management with parameters |
8
60 days from date of enroll ment |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 4 |
|
Date of First Enrollment (India)
|
30/04/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a Non –
Interventional Observational study. After obtaining informed consent from
patient for study participation, the doctor will prescribe the herbal nutritional
supplement as part of routine clinical practice based on the doctor’s
knowledge and experience. After four weeks of treatment the patient will be requested to
visit the hospital for follow-up. A
total of 50 (25- subjects new
hypertensive i.e <1 Year with HTN; 25 subjects with long term Hypertensive
i.e >1 year with HTN) subjects with age group >45
years and surviving with standard medication should be considered to initiate treatment with Herbal nutritional
Supplement (Cuminum cyminum, Zingiber officinale, Myristica fragrans, Elettaria
cardamomum, Linum usitatissimum, Psidium guajava ,Curcuma longa, Cinnamomum
verum, Syzygium aromaticum, Glycyrrhiza glabra, Trigonella foenum-graecum,
Foeniculum vulgare, Nigella sativa) for a period of 6 months to stusy the effucacy of the herbal suppliment in mange ment of hypertension |