| CTRI Number |
CTRI/2018/11/016247 [Registered on: 01/11/2018] Trial Registered Prospectively |
| Last Modified On: |
30/10/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
STUDY OF THE EFFICACY OF KATUKADYA GHAN VATI IN MANAGEMENT OF HYPERTENSION. |
|
Scientific Title of Study
|
STANDARD CONTROLLED RANDOMIZED CLINICAL STUDY OF THE EFFICACY OF KATUKADYA GHAN
VATI IN MANAGEMENT OF UCHCHA-RAKTADAAB with special reference to ESSENTIAL
HYPERTENSION.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Medha Joshi |
| Designation |
professor |
| Affiliation |
CARC college Nigadi,Pune |
| Address |
P.D.E.As college of Ayurved and Research Center,Nigadi
Pradhikaran Pune.
Pune
MAHARASHTRA
411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9881465798 |
| Fax |
|
| Email |
medhamaheshjoshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Medha Joshi |
| Designation |
professor |
| Affiliation |
CARC college Nigadi,Pune |
| Address |
P.D.E.As college of Ayurved and Research Center,Nigadi
Pradhikaran Pune.
Pune
MAHARASHTRA
411044
MAHARASHTRA
411044
India |
| Phone |
9881465798 |
| Fax |
|
| Email |
medhamaheshjoshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrPranav Puranik |
| Designation |
PG student |
| Affiliation |
carc college,nigadi |
| Address |
P.D.E.As college of Ayurved and Research Center,Nigadi
Pradhikaran Pune.
Pune
MAHARASHTRA.
Pune
MAHARASHTRA
411044
India |
| Phone |
9404712825 |
| Fax |
|
| Email |
prnv.puranik@gmail.com |
|
|
Source of Monetary or Material Support
|
| P.D.E.As college of Ayurved and Research Center,Nigadi
Pradhikaran Pune.
Pune
MAHARASHTRA |
|
|
Primary Sponsor
|
| Name |
carc college |
| Address |
P.D.E.As college of Ayurved and Research Center,Nigadi
Pradhikaran Pune
MAHARASHTRA |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrMedha Joshi |
carc college |
Kayachikitsa department P.D.E.As college of Ayurved and Research Center,Nigadi
Pradhikaran Pune.
MAHARASHTRA.
Pune
MAHARASHTRA |
9881465798
medhamaheshjoshi@gmail.com |
| Dr medha Joshi |
CARC hospital |
Ayurved rugnalaya kayachikitsa department opd ,room no 117,Pradhikaran near bhel chouwk,Nigadi Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9881465798
medhamaheshjoshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ICE |
Approved |
| MUHS |
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 |
Katukadya ghan vati |
Katukadya ghan vati 500mg will be prepared in pharmacy & Standardization
Will be done from recognized institute.Katukdya Ghan Vati 500mg 2BD for 30 days |
| Comparator Agent |
Tab. Atenolol 25 mg |
Tab. Atenolol 25 mg 1 od for 30 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having primary hypertension recently diagnosed.
2) Age : 30 to 70 years.
3) Gender : Irrespective of gender.
4) Stage 1 hypertension i. e. Systolic blood pressure is upto 160 mm of Hg &/or
diastolic blood pressure upto100 mm of Hg. |
|
| ExclusionCriteria |
| Details |
1) Hypertension Secondary to Any major Systemic illness.
2) Patient with known case of acute coronary syndrome, cardiomyopathies,
Myocardial infarction, stroke.
3) Pregnant, lactating women & women on oestrogen replacement therapy.
4) Alcohol & drug abusers
5) Accelerated & malignant hypertension
6) Complicated multiple organ failure conditions.
7) Encephalopathy
8) Mentally ill patients |
|
|
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 |
To assess the efficacy of the Katukadya Ghan Vati in uchcha raktdaab i.e.
essential hypertension. |
To assess the efficacy of the Katukadya Ghan Vati in uchcha raktdaab i.e.
essential hypertension in 30days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To assess the efficacy of Atenolol in uchcha raktdaab i.e. essential hypertension.
2) To assess the adverse events |
For one month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
07/11/2018 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hypertension is one of the fetal disease now a days.Our ancient Acharyas of Ayurveda explained various important properties of
Herbal drugs in Samhitas & Nighantus.With the help of this topic, we are going to
assess the effect of the Katukadya Ghan Vati on essential hypertension.Though the prevalence of hypertension is increasing constanly, there is
less previous research work done in ayurveda as compare to preavalence. So this is
the humble attempt to do research work with Katukadya ghan vati on essential
hypertension which may be useful to overcome this problem. |