| CTRI Number |
CTRI/2024/03/064721 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
17/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical trial of Tagar Tablet in Hypertension. |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate an add on effect of Tagar Vati in the management of Essential 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 |
Yogesh Tukaram Kotangale |
| Designation |
Associate Professor |
| Affiliation |
MAMS Sumatibhai Shah Ayurved College Hdapsar Pune |
| Address |
O.P.D. NO.2
First Floor
Kayachikitsa Department
Saneguruji Arogya Kendra
Malwadi
Hadapsar
Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
09423218193 |
| Fax |
|
| Email |
drytk@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidya Rajendra Jatti |
| Designation |
P.G. student |
| Affiliation |
MAMS Sumatibhai Shah Ayurved College Hdapsar Pune |
| Address |
O.P.D. NO.2
First Floor
Kayachikitsa Department
Saneguruji Arogya Kendra
Malwadi
Hadapsar
Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9373692663 |
| Fax |
|
| Email |
vidyajatti06@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vidya Rajendra Jatti |
| Designation |
P.G. student |
| Affiliation |
MAMS Sumatibhai Shah Ayurved College Hdapsar Pune |
| Address |
O.P.D. NO.2
First Floor
Kayachikitsa Department
Saneguruji Arogya Kendra
Malwadi
Hadapsar
Pune
MAHARASHTRA
411028
India |
| Phone |
9373692663 |
| Fax |
|
| Email |
vidyajatti06@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAMS Sumatibhai Shah Ayurved College Hadapsar Pune 411028 |
|
|
Primary Sponsor
|
| Name |
Dr Vidya Rajendra Jatti |
| Address |
O.P.D. NO.2
First Floor
Kayachikitsa Department
Saneguruji Arogya Kendra
Malwadi
Hadapsar
Pune |
| Type of Sponsor |
Other [Self] |
|
|
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 Vidya Rajendra Jatti |
Saneguruji Arogya Kendra |
O.P.D. NO.2
First Floor
Kayachikitsa Department
Saneguruji Arogya Kendra
Malwadi
Hadapsar
Pune
Pune
MAHARASHTRA |
9373692663
vidyajatti06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MAMs Sumatibhai Shah Ayurved Mahavidyalaya and Sane Guruji Arogya Kendra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: RAKTAVRUTAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Tagar Vati, Reference: Kaidev Nighantu, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Beta blocker | As prescribed by Physician |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having Stage I hypertension, isolated systolic and isolated diastolic hypertension.
2. Patients who is known case of Hypertension but not suffering from more than 10 years. Also known case of hypertension with or without antihypertensive.
3. Shirashool, Bhrama, Klama, Hridspandana, Anidra, Swedadhikya ,Shwaskashtata patient having these symptoms of Hypertension will be included in the clinical study .
4. Patients in between 20 to 60 years of age.
5. Patients having serum creatinine level less than 1.5 mg/dl.
6. Patients with raised blood pressure with Beta blocker. |
|
| ExclusionCriteria |
| Details |
1. Patients having Stage II, stage III and above known case of hypertension will be excluded.
2. Pregnant women and lactating mothers.
3. Patient suffering from any other serious systemic illness like cerebrovascular diseases, Acute Haemorrhagic conditions, Acute septic shock etc. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Blood pressure monitoring
2.Serum creatinine
3.Lipid Profile
4. ECG |
At base line, 15 days and 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| Date of Study Completion (India) |
15/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="15" |
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
|
Hypertension is one of largest non-communicable disease in India.[8] It causes more death worldwide, due to cardiovascular diseases. There are lots of medicinal availability for blood pressure treatment but it is limited due to phenomena of drug inertia. The national health and nutritional examination survey reported that around 16 million hypertensive patients are on medication but still they do not have controlled blood pressure.[9] People who are suffering from hypertension started antihypertensive generally for lifetime. This leads into some toxicity or side effects of the medicines. Side effects of beta blocker may include hypotension, bradycardia, dizziness, cold fingers, insomnia, fatigue, impotence etc. Severe side effects may include bronchoconstriction, arrhythmias, hypoglycemia etc. Modern Medicines are usually single targeted and long term use of any single group leads to treatment failure in long term. Addition of multiple antihypertensive is usual observation in routine clinical practice. In modern medicine anti-hypertensive drugs lower the high blood pressure but do not wholesomely eradicate the risk of cardiac-cerebrovascular-renal-ophthalmic involvement, But Ayurveda therapy can minimize the risk factor in a better way. Hence for the hypertension cases, we have chosen Tagar Vati. Contents in the Tagar Vati i.e. Tagar is readily available, and this medicine is available throughout in India. |