| CTRI Number |
CTRI/2022/12/047918 [Registered on: 06/12/2022] Trial Registered Prospectively |
| Last Modified On: |
29/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Effect of ayurveda oral medicine
in the management of high blood pressure. |
|
Scientific Title of Study
|
A Clinico-Comparative study of Kakubhadi Churna and Rasayana Vati, in he management of Raktagatavata 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 |
Nikita Jamadari |
| Designation |
Post graduation scholar |
| Affiliation |
Government Dhanwantari ayurveda medical college and hospital |
| Address |
OPD no. 27, department of Kayachikitsa, Government Dhanwantari Ayurveda hospital, Chimanganj police station, Ujjain
Mangalnath road, Ujjain, Madhya Pradesh
Ujjain
MADHYA PRADESH
456001
India |
| Phone |
6263854200 |
| Fax |
0 |
| Email |
nikkujamadari12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naresh Jain |
| Designation |
Associate professor |
| Affiliation |
Government Dhanwantari ayurveda medical college ujjain |
| Address |
OPD no. 27 Kayachikitsa department Govt. Dhanwantari Ayurveda hospital Chimanganj police station Ujjain
Mangalnath road Ujjain, Madhya Pradesh
Ujjain
MADHYA PRADESH
456001
India |
| Phone |
9826064756 |
| Fax |
0 |
| Email |
nareshjainujn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naresh Jain |
| Designation |
Associate professor |
| Affiliation |
Government Dhanwantari ayurveda medical college ujjain |
| Address |
OPD no. 27 Kayachikitsa department Govt. Dhanwantari Ayurveda hospital Chimanganj police station Ujjain
Mangalnath road Ujjain Madhya Pradesh
Ujjain
MADHYA PRADESH
456001
India |
| Phone |
9826064756 |
| Fax |
0 |
| Email |
nareshjainujn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt. Dhanwantari Ayurveda Medical college and hospital ujjain |
|
|
Primary Sponsor
|
| Name |
Govt. Dhanwantari Ayurveda Medical College and Hospital ujjain |
| Address |
Mangalnath road, ujjain ,madhya pradesh |
| Type of Sponsor |
Government medical college |
|
|
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 |
| nikita |
Dhanwantari Ayurveda Medical Hospital, Ujjain |
OPD 27 Kayachikitsa department Govt. Dhanwantari Ayurveda Hospital Chimanganj police station Ujjain
Ujjain
MADHYA PRADESH |
6263854200
0
nikkujamadari12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethical committee Govt. Dhanwantari Ayurveda Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: SIRAGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kakubhadi churna, Reference: Bhaishajya Ratnavali Hridhya roga chikitsa prakaran 33/22-23, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: -0 | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Rasayana Vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: -0 | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kakubhadi Churna, Reference: Bhaisjya ratnavali hridhya roga chikitsa prakaran 33/22-23, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: -Kakubhadi churna will be given with Rasayana Vati 2 Tab (250 each) BID Bhaishajya kala Adhobhakta duration 2 months Anupana lukewarm |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patients presenting with classical sign and symptoms as described in ayurvedic and modern medicine |
|
| ExclusionCriteria |
| Details |
1 endocrine disease
2 renal disease
3 hypertension with cerebral complications
4 cerebral hemorrhages, convulsive seizures
5. toxemia of pregnancy
6 poisoning
7 pre eclampsia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
during this trial patients will be assessed on following parameters
subjective criteria
systolic blood pressure
diastolic blood pressure
headache
dizziness
palpitation
edema
epitaxis
excessive sweating
objective criteria |
1)At the baseline day
2)after completion of trial i.e after 2 months
3) total study period of 15 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
12/12/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
this study is a randomised interventional clinical trial to evaluate the efficacy of Kakubhadi Churna and Rasayana Vati in the management of Raktagatavata w.s.r. to Essential hypertension. Total no. of patients 60 will be enrolled in present study. selected patients will be divided into 3 groups on the basis of computer generated randomization method.
group A 20 patients will be given Rasayana vati 2 tablets twice a day with lukewarm water
group B 20 patients will be given kakubhadi churna 3 gm twice a day with lukewarm water
group C 20 patients will be given both Rasayana vati and Kakubhadi churna twice daily with lukewarm water |