| CTRI Number |
CTRI/2025/03/081854 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study comparing the effect of kakmachi kwath to that of Pathya Ahar and Vihar on raised blood pressure |
|
Scientific Title of Study
|
A Randomised comparitive clinical study to evaluate the efficacy of Kakmachi kwath and Hridya Pathya ahara along with vihar in the management of Vyanabala Vaishamya w.s.r. to 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 Shikha Singh |
| Designation |
MD Scholar |
| Affiliation |
Government Ayurvedic College and hospital , Patna, Bihar-800003 |
| Address |
Swasthavritta and Yoga Department, Government Ayurvedic College and Hospital,Kadamkuan,Patna
Patna
BIHAR
800003
India |
| Phone |
9718039372 |
| Fax |
|
| Email |
shikhasingh.244@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita Pandey |
| Designation |
Professor |
| Affiliation |
Government Ayurveda college and Hospital |
| Address |
Swasthavritta and Yoga Department, Government Ayurveda College and Hospital, Kadamkuan, Patna
Patna
BIHAR
800003
India |
| Phone |
9431259606 |
| Fax |
|
| Email |
drpsunita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunita Pandey |
| Designation |
Professor |
| Affiliation |
Government Ayurveda college and Hospital |
| Address |
Swasthavritta and Yoga Department, Government Ayurveda College and Hospital, Kadamkuan, Patna
BIHAR
800003
India |
| Phone |
9431259606 |
| Fax |
|
| Email |
drpsunita@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic college and Hospital, Kadamkuan, Patna 800003 |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College and Hospital |
| Address |
Departmemt of Swasthavritta and Yoga, Government Ayrvedic College and Hospital, Kadamkuan, Patna, Bihar-800003 |
| 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 |
| Dr Shikha Singh |
OPD no. 8 ,Swasthavritta and Yoga Department , Government Ayurvedic college and Hospital |
Government Ayurvedic College and Hospital, Kadamkuan, Patna
Patna
BIHAR |
9718039372
shikhasingh.244@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. Ayurveda Condition: VYANAVATAKOPAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kakmachi Kwath, Reference: Bhao Prakash, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:Hridya Pathya Ahara, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Grade 1 hypertensive and pre-hypertensive
newly diagnosed primary asymptomatic essential hypertension
Newly diagnosed symptomatic essential hypertension |
|
| ExclusionCriteria |
| Details |
Age below 25years and above 60years.
Acute organ failure, CVA
Secondary Hypertension
Hypertensive Retinopathy
Malignancy
History ofliver disease, malignant hypertension
The patient who responded with salt restricted diet. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to bring raised blood pressure within normal range and maintain it by the use of Kakmachi Kwath |
15days follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to asses the efficacy of Kakmachi Kwath |
60 Days |
|
|
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 |
|
Date of First Enrollment (India)
|
15/04/2025 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Today non-communicable diseases are majorly prevailing in our society with hypertension being a leading cause of heart diseases and death. Changing diet and lifestyle along with some ayurveda drug can be a game changer in this scenario.In OPD we encounter young patients too with a deranged blood pressure leading to stress and anxiety among the younger age group. WHO considers hypertension as a public health problem thus major steps are being taken including awareness and education programs to reduce the cases of Hypertension. |