| CTRI Number |
CTRI/2025/01/079564 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Add on effect] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To see add on effect of kantakari vati in essential hypertension |
|
Scientific Title of Study
|
A Ranadomized controlled trial to evaluate an add on effect of kantakari Vati with ARBs with or without diuretic in managemant 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 |
Dr Vijayalaxmi Sujay Patil |
| Designation |
Associate Professor |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar |
| Address |
M.A.M.’s Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi, Hadapsar, Pune
Sane Guruji Arogya kendra,OPD No.2,Kayachikitsa department 1st floor,Maharashtra State, India.
Pune
MAHARASHTRA
411028
India |
| Phone |
8484830574 |
| Fax |
- |
| Email |
drvrmane@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priya Pravin Shevale |
| Designation |
P. G. Scholar |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar |
| Address |
M.A.M.’s Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi, Hadapsar,Sane guruji Arogya Kendra,OPD no.2,1st floor , Kayachikitsa department Pune-411028, Maharashtra State, India.
M.A.M.’s Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi, Hadapsar,Sane guruji Arogya Kendra,OPD no.2,1st floor Kayachikitsa department Pune-411028, Maharashtra State, India.
Pune
MAHARASHTRA
411028
India |
| Phone |
08484830574 |
| Fax |
- |
| Email |
priyashevale4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priya Pravin Shevale |
| Designation |
P. G. Scholar |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya Hadapsar |
| Address |
M.A.M.’s Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi, Hadapsar,Sane guruji arogya Kendra,1st floor,OPD no.2,kayachikitsa department, Pune-411028, Maharashtra State, India.
M.A.M.’s Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi, Hadapsar,Sane guruji Arogya Kendra,1st floor,OPD no.2,kayachikitsa department Pune-411028, Maharashtra State, India.
Pune
MAHARASHTRA
411028
India |
| Phone |
08484830574 |
| Fax |
- |
| Email |
priyashevale4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sane guruji Arogya Kendra,1st floor,OPD no.2,kayachikitsa department,Malwadi,Hadapsar,Pune,411028 |
|
|
Primary Sponsor
|
| Name |
Dr Priya Pravin Shevale |
| Address |
MAMs Sumatibhai Shah Ayurveda Mahavidyalaya,Hadapsar,pune,pin code-411028 |
| 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 Priya Shevale |
Sane Guruji Arogya Kendra |
Kayachikitsa Department,OPD no 2, Ground floor,Malwadi, Hadapsar, Pune-411028, Maharashtra State, India.
Pune
MAHARASHTRA |
9922191325
-
priyashevale4@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 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kantakari, Reference: Bhavprakash Nighantu, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: koshna jala), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | ARBs | Angiotensin Receptor Blockers,form:tablets,Dose:as prescribed by physician
Duration: 30 days |
|
|
|
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.Age of the patient between 20 to 60 years.
4. Shirashool, Klama, Hridspandana, Bhrama patient having these symptoms of Hypertension will be included in the clinical study.
5. Patients taking Angiotensin Receptor Blockers with or without diuretic and still having raised blood pressure.
6.Diabetic patients with ongoing allopathy medications only.
7.Patient on previous ayurvedic medications, 7 days washout period will be given to avoid
drug interaction.
8. Patients having serum creatinine level less than 1.4 mg/dl. |
|
| ExclusionCriteria |
| Details |
1.Patients having Stage II, hypertensive crisis will be excluded.
2.Patient suffering from any other serious systemic illness like Acute cerebrovascular
diseases, Acute coronary syndrome, Acute Haemorrhagic conditions, Acute septic shock etc.
3.Secondary Hypertension or Accelerated Hypertension.
4. Pregnant women and lactating mothers. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the add on effect of Kantakari Vati with ARBs with or without diuretic
in Vyanodan kala in decreasing the sign and symptoms of essential hypertension in
duration of 30 days. |
inclusion day,15th day,30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study the Ayurveda concepts of Hypertension.
2. To see add on effect of Kantakari Vati in Essential Hypertension. |
Inclusion day,15th day,30th day |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
08/02/2025 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Patient between 20 to 60 years of age taking ARBs with or without diuretic antihypertensive but still
having systolic blood pressure of ≥ 130 mmHg and/or diastolic blood pressure of ≥80 mmHg
with or without symptoms Shirshoola (Headache), Hridspandana (Palpitations), Bhrama
(Giddiness), Klama (Fatigue) will be included in this study and will be treated with kantakari
vati.
1) INCLUSION CRIETERIA:
1. Patients having Stage I hypertension, isolated systolic and isolated diastolic hypertension.
2.Age of the patient between 20 to 60 years.
4. Shirashool, Klama, Hridspandana, Bhrama patient having these symptoms of
Hypertension will be included in the clinical study.
5. Patients taking Angiotensin Receptor Blockers with or without diuretic and still having raised blood
pressure.
6.Diabetic patients with ongoing allopathy medications only.
7.Patient on previous ayurvedic medications, 7 days washout period will be given to avoid
drug interaction.
8. Patients having serum creatinine level less than 1.4 mg/dl.
2) EXCLUSION CRITERIA:
1. Patients having Stage II, hypertensive crisis will be excluded.
2. Patient suffering from any other serious systemic illness like Acute cerebrovascular
diseases, Acute coronary syndrome, Acute Haemorrhagic conditions, Acute septic shock etc.
3.Secondary Hypertension or Accelerated Hypertension.
4. Pregnant women and lactating mothers. |