| CTRI Number |
CTRI/2023/10/059157 [Registered on: 26/10/2023] Trial Registered Prospectively |
| Last Modified On: |
23/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of Aahar vidhi vidhan in the management of essential hypertension. |
|
Scientific Title of Study
|
Randomised Controlled Clinical trial to evaluate the add on effect of Aahar vidhi vidhan in the management of essential 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 Anagha Kiran Yadav |
| Designation |
Final M.D Ayurveda Scholar |
| Affiliation |
Yashwant Ayurveda College and P.G Research Center, Kodoli |
| Address |
Yashwant Ayurveda College & P.G Research Center Kodoli Tal. Panhala Dist. Kolhapur.
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9673048074 |
| Fax |
|
| Email |
yadav.anagha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr U K Bande |
| Designation |
Guide & HOD Kriya Sharir Department |
| Affiliation |
Yashwant Ayurveda College and P.G Research Center, Kodoli |
| Address |
Yashwant Ayurveda College & P.G Research Center Kodoli Tal. Panhala Dist. Kolhapur.
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9011090327 |
| Fax |
|
| Email |
ukbande@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anagha Kiran Yadav |
| Designation |
Final M.D Ayurveda Scholar |
| Affiliation |
Yashwant Ayurveda College and P.G Research Center, Kodoli |
| Address |
Yashwant Ayurveda College & P.G Research Center Kodoli Tal. Panhala Dist. Kolhapur.
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9673048074 |
| Fax |
|
| Email |
yadav.anagha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurved Hospital & PG Research Center, Kodoli, Tal. Panhala, Dist. Kolhapur |
|
|
Primary Sponsor
|
| Name |
Dr Anagha Kiran Yadav |
| Address |
Yashwant Ayurveda College & P.G Research Center Kodoli Tal. Panhala Dist. Kolhapur. |
| Type of Sponsor |
Other [Self] |
|
|
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 Anagha Kiran Yadav |
Yashwant Ayurveda Hospital |
Room No. 15, Ground Floor, Kayachikitsa Department
Kolhapur
MAHARASHTRA |
9673048074
yadav.anagha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Yashwant Ayurvedic College, Kodoli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: RASAVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:1. Hot food
2. Two spoonfuls of ghee
3. Right quantity
4. After digestion of the previous meal
5. Eating using clean utensils
6. Concentrating on food while eating
7. Eating considering prakriti
8. Following the Ashthaaharvidhividhan, Apathya:1. Cold food
2. Food that is antagonist in nature
3. Eating hurriedly
4. Eating too leisurely
5. Laughing or speaking while eating | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:yes, Pathya:Everything the patient eats regularly., Apathya:Allergic Food Items to the patient. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Pre-diagnostic essential hypertensive volunteer patients taking anti-hypertensive drugs. |
|
| ExclusionCriteria |
| Details |
1. Having a history of major illness e.g. severe diseases of CVS, CNS & RS.
2. Having a history of major surgeries
3. Having any congenital abnormalities.
4. Having any hormonal problems.
5. Diabetics |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This study will note the changes in the Blood Pressure of a pre-diagnosed essential hypertensive patient after initiation of Aahar Vidhi Vidhan to check whether it has a significant role in the management of essential Hypertension. |
The Blood Pressure will be recorded at the end of 2 weeks and then 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| This study will also see whether the lifestyle & diet changes do or do not affect the blood pressure of a pre-diagnosed hypertensive patient. |
Blood Pressure will be checked at the end of 2 weeks & then at the end of 2 weeks. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
06/11/2023 |
| 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="6"
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
|
This study mainly focuses to find whether there is any significant add on effect of Aahar Vidhi Vidhan in the management of Essential Hypertension. Steps in Study- Pre diagnosed Essential Hypertensive Patients will be identified, consent will be taken, Case taking using case Record form and Questionnaire and recording Blood Pressure, Group A will be kept on their respective antihypertensives only and Aahar Vidhi Vidhan will be initiated in Group B along with Antihypertensives , Follow up after 15 days to blood pressure, Final Blood Pressure Recording and Case taking for Statistical analysis. |