| CTRI Number |
CTRI/2019/09/021192 [Registered on: 12/09/2019] Trial Registered Prospectively |
| Last Modified On: |
13/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on HYPERTENSION in Siddha |
|
Scientific Title of Study
|
AN OPEN CLINICAL TRIAL ON ESSENTIAL HYPERTENSION-KURUTHIAZHAL MANAGED WITH KURUTHIAZHAL KUDINEER (KK) A SIDDHA HERBAL CONCOCTION |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR T Thamizhkalai |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Noi Naadal National Institute of Siddha Tambaram Sanatorium
Chennai
Kancheepuram
TAMIL NADU
Department of Noi Naadal National Institute of Siddha Tambaram Sanatorium
Chennai
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9003654710 |
| Fax |
|
| Email |
thamizhkalai678@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G J Christian |
| Designation |
Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Noi Naadal National Institute of Siddha Tambaram Sanatorium
Chennai
Kancheepuram
TAMIL NADU
600047
Department of Noi Naadal National Institute of Siddha Tambaram Sanatorium
Chennai
Kancheepuram
TAMIL NADU
600047
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9962545930 |
| Fax |
|
| Email |
christianvijila@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G J Christian |
| Designation |
Professor |
| Affiliation |
National Institute of Siddha |
| Address |
Department of Noi Naadal National Institute of Siddha Tambaram Sanatorium
Chennai
Kancheepuram
TAMIL NADU
600047
Department of Noi Naadal National Institute of Siddha Tambaram Sanatorium
Chennai
Kancheepuram
TAMIL NADU
600047
Kancheepuram
TAMIL NADU
600047
India |
| Phone |
9962545930 |
| Fax |
|
| Email |
christianvijila@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayothidoss Pandithar Hospital
National Institute of Siddha
Tambaram Sanatorium
chennai |
|
|
Primary Sponsor
|
| Name |
Ayothidoss pandithar Hospital |
| Address |
Department of Noi Naadal National Institute of Siddha Tambaram Sanatorium
Chennai 47 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Thamizhkalai T |
Ayothidoss Pandithar Hospital |
Department of Noi Naadal National Institute of Siddha Tambaram Sanatorium
Chennai 47
Kancheepuram
Kancheepuram
TAMIL NADU |
9003654710
thamizhkalai678@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, (2) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
KURUTHI AZHAL KUDINEER |
Oral dose 30ML Twice daily for 4 months |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Age : 25 to 60 years
2 Patients who are reported with complaints and / or findings of primary hypertension at NIS OPD/IPD with or without Anti hypertensive medication
3 Gender: All genders
SYSTOLIC PRESSURE: 140-179 mmHg [ Grade I & II – Stage I ]
DIASTOLIC PRESSURE: 90-109 mmHg [ Grade I & II – Stage I ]
|
|
| ExclusionCriteria |
| Details |
1 Secondary hypertension due to following causes
Chronic kidney disease
MRD (Medical Renal Disease) as found out by USG
Symptom of orthostatic hypertension suggestive of Pheochromocytoma
2 Hypertension associated
Cerebro vascular disease
Cardio vascular disease
Ischemic heart disease
Obstructive sleep apnea
Thyroid dysfunction
Uncontrolled diabetes
3 Vulnerable group-Pregnancy induced hypertension
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Good – reduction of BP down to 130/80 mmHg and below.
Moderate - reduction of BP down to 140/90 mmHg and below.
Poor – Partial / No reduction in BP but missing the target.
|
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Good – reduction of BP down to 130/80 mmHg and below.
Moderate - reduction of BP down to 140/90 mmHg and below.
Poor – Partial / No reduction in BP but missing the target. |
1 year |
|
|
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 2 |
|
Date of First Enrollment (India)
|
12/09/2019 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hypertension is the most common cardiovascular diseases and is a major public health issue in developed as well as developing countries. Although it is common and readily detectable, it can often lead to lethal complication, if left treated.Primary hypertension is the most common type of hypertension, accounting 95% of hypertensive patients. It has no identifiable cause. It is the primary cause of stroke, coronary artery diseases and sudden cardiac death. In Worldwide, the majority of diagnosed hypertensive patients are inadequately controlled. In National Institute of Siddha hospital ,the number of Kuruthiazhal (hypertension) patients are gradually increasing. Many more Siddha formulations are mentioned in Siddha text for the treatment of Kuruthiazhal. According to the Siddha literature, selected drug is indicated for kuruthiazhal. Here I have chosen Kuruthiazhal kudineer being used by many traditional practitioners and found to be effective in management of hypertension |