| CTRI Number |
CTRI/2021/08/035692 [Registered on: 16/08/2021] Trial Registered Prospectively |
| Last Modified On: |
13/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
study of Hridroga and evaluation of diet and lifestyle modification |
|
Scientific Title of Study
|
Aetiopathological study of Vatika Hridroga and evaluation of diet and lifestyle modification in its samprapti vighatana |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjay Kumar Singh |
| Designation |
professor |
| Affiliation |
Rishikul campus, UAU Hardwar |
| Address |
OPD no 21 &IPD of Rog Nidan Evam Vikriti Vigyan Department,Rishikul Campus, UAU,Hardwar
Rog Nidan Evam Vikriti Vigyan Department,Rishikul Campus, UAU,Hardwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
7060754892 |
| Fax |
|
| Email |
drsanjaysingh1970@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjay Kumar Singh |
| Designation |
professor |
| Affiliation |
Rishikul campus, UAU Hardwar |
| Address |
OPD no 21 &IPD of Rog Nidan Evam Vikriti Vigyan Department,Rishikul Campus, UAU,Hardwar
Rog Nidan Evam Vikriti Vigyan Department,Rishikul Campus, UAU,Hardwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
7060754892 |
| Fax |
|
| Email |
drsanjaysingh1970@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjay Kumar Singh |
| Designation |
professor |
| Affiliation |
Rishikul campus, UAU Hardwar |
| Address |
OPD no 21 &IPD of Rog Nidan Evam Vikriti Vigyan Department,Rishikul Campus, UAU,Hardwar
Rog Nidan Evam Vikriti Vigyan Department,Rishikul Campus, UAU,Hardwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
7060754892 |
| Fax |
|
| Email |
drsanjaysingh1970@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul Campus, Uttrakhand Ayurveda University |
|
|
Primary Sponsor
|
| Name |
Rishikul Campus Uttrakhand Ayurveda University |
| Address |
Rishikul Campus, Uttrakhand Ayurveda University
Department of Rognidan Evam Vikriti Vigyan |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Anchal Jaiswal |
Rishikul Campus, UAU, Hardwar |
OPD no.21 & IPD of Rog Nidan Evam Vikriti Vigyan Department, Rishikul Campus, UAU, Hardwar
UTTARANCHAL
Hardwar
UTTARANCHAL |
08923992107
anchalj536@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I209||Angina pectoris, unspecified. Ayurveda Condition: HRUDROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: bramha muhurta rising, usapana,aerobic exercise like yoga, surya namaskar, running, swimming, cycling, skipping rope.• Practice anulom vilom, bhamri pranayam, shavasan daily 5-7 minutes per day., Ritucarya: , Acara Rasayana:•Avoid Krodha (anger), Chinta (Excessive thinking), Adhika Sambhashanama (Excessive talking).
• To have pleasant and optimistic thoughts for oneself and others.
, Other:, Pathya/Apathya:yes, Pathya:Have old shali rice, wheat, mudga (green gram), draksha (munakka) cabbage, tendil, ginger, garlic, shunthi (dry ginger) puran kushmand (old pumpkin) Gourd, Pomegranate, grapes ,lemon, orange, honey, hot water, ajawayana, almonds, skimmed milk egg white, salmon fish, safflower oil, sunflower oil, low sodium salt intake., Apathya:ailam (Saturated fats), Viruddha ahara (Incompatible diet), Excessive dry food, Black gram, kidney beans, egg yolk, red meat, fried food, butter, whole fat dairy products. |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patient having significant ECG finding
patient having classical symptoms of vatika hridroga
|
|
| ExclusionCriteria |
| Details |
patient of other cardiac disease except IHD
patient of diabetes
patient suffering from other chronic disorders TB & other systemic disorder |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of diet and lifestyle modification in samprapti vighatana of Vatika Hridroga |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment will be done on the basis of subjective and objective criteria |
3 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
16/08/2021 |
| 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="0"
Months="9"
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
|
Hridaya is one of the three marmas of body . It is moola of pranavaha srotas. In ayurveda all the painful heart diseases comes under the broad classification of Hridroga. Prevalence of vatika hridroga is more so it needs assessment of etiological factors and to prevent its episodes we need some lifestyle modification. In order to treat any disease we must practice nidana privarjan. avoid stressful activities, take healthy diet, and should excercise daily. |