| CTRI Number |
CTRI/2021/10/037162 [Registered on: 07/10/2021] Trial Registered Prospectively |
| Last Modified On: |
30/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Hypertension through Aswagandha Churna |
|
Scientific Title of Study
|
A Nidanatmaka (Epidemiological) Study on Raktagata Vata (Hypertension) and An Upashayatmaka (Therapeutic) Study to Evaluate The Efficacy of Aswagandha Churna. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Archana Kumari Rai |
| Designation |
MD (Ay) Scholar |
| Affiliation |
Government Ayurvedic College and Hospital Patna |
| Address |
Department of Rognidan and Vikriti Vigyan, GACH Patna
Department of Rognidan and Vikriti Vigyan, GACH Patna
Patna
BIHAR
800003
India |
| Phone |
9113774797 |
| Fax |
|
| Email |
archanarai0494@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amrendra Kumar Singh |
| Designation |
Associate Professor (Ay) |
| Affiliation |
Government Ayurvedic College and Hospital Patna |
| Address |
Department of Rognidan and Vikriti Vigyan, GACH Patna
Department of Rognidan and Vikriti Vigyan, GACH Patna
Patna
BIHAR
80003
India |
| Phone |
7013506981 |
| Fax |
|
| Email |
singh.amrendra70@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Archana Kumari Rai |
| Designation |
MD (Ay) Scholar |
| Affiliation |
Government Ayurvedic College and Hospital Patna |
| Address |
Department of Rognidan and Vikriti Vigyan, GACH Patna
Department of Rognidan and Vikriti Vigyan, GACH Patna
Patna
BIHAR
80003
India |
| Phone |
9113774797 |
| Fax |
|
| Email |
archanarai0494@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital Patna |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College and Hospital Patna |
| Address |
Department of Rognidan and Vikriti Vigyan Government Ayurvedic College and Hospital Patna |
| 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 Archana Kumari Rai |
Government Ayurvedic College Patna |
Department of Rognidan and Vikriti Vigyan Government Ayurvedic College Patna
Patna
BIHAR |
9113774797
archanarai0494@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:I00-I99||Diseases of the circulatory system. Ayurveda Condition: Raktgata Vata, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Aswagandha churna, Reference: Bhavprakash , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -MILK or Luke warm water), Additional Information: no |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient having classical symptoms of Raktagata Vata given in samhitas will be taken. |
|
| ExclusionCriteria |
| Details |
Pregnant women and lactating mother.
Patient suffering from genetical and congenital disease.
Patient having BP more than 200/100mmHg are excluded.
Patient having any complication like Diabetes and cancer. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in sign and symptom of Raktagata vata |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in Raktagata vata
Improvement in sign and symptoms of Raktagata vata |
2 months
2 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/10/2021 |
| 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) |
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
|
Hypertension is an important worldwide public health challenge and remains a cause of morbidity and mortality worldwide.In ayurveda the symptoms of raktagata vata very much resembles with hypertension.As we know the description about raktagata vata and hypertension is avilable in ancient literature but the correlative interpretation between Raktagata vata and Hypertension has not been clear.So, study efforts are done to understand the concept of Raktagata vata in terms of Nidan Panchak and also to collect the various preventive measures for hypertension in Ayurveda such as life style management and upashyatmaka role of Ashwagandha churna on Hypertension.Potent anti- stress and anti-anxiety effect helps to reduce Hypertension. |