| CTRI Number |
CTRI/2021/01/030220 [Registered on: 04/01/2021] Trial Registered Prospectively |
| Last Modified On: |
04/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of Hypertension through Pippalyadi Ayurvedic yog |
|
Scientific Title of Study
|
Pharmaco-Therapeutic Evalution of Pippalyadiyog [kalpit yog] in the Management of Uccharaktchap W.S.R. to Hypertension |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR KUSUM GEHLOT |
| Designation |
MD SCHOLAR |
| Affiliation |
University College of Ayurved |
| Address |
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University,P.G. Department of Dravyaguna Vigyan,Karwad ,Jodhpur,Rajasthan
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University,P.G. Department of Dravyaguna Vigyan,Karwad ,Jodhpur,Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8058513105 |
| Fax |
|
| Email |
gahlotk42@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajendra prasad Purvia |
| Designation |
Assistant ProfeSsor |
| Affiliation |
University College of Ayurved |
| Address |
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University,P.G. Department of Dravyaguna Vigyan,Karwad ,Jodhpur,Rajasthan
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University,P.G. Department of Dravyaguna Vigyan,Karwad ,Jodhpur,Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9782230577 |
| Fax |
|
| Email |
drrajpurvia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR KUSUM GEHLOT |
| Designation |
MD SCHOLAR |
| Affiliation |
University College of Ayurved |
| Address |
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University,P.G. Department of Dravyaguna Vigyan,Karwad ,Jodhpur,Rajasthan
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University,P.G. Department of Dravyaguna Vigyan,Karwad ,Jodhpur,Rajasthan
Jodhpur
RAJASTHAN
342037
India |
| Phone |
8058513105 |
| Fax |
|
| Email |
gahlotk42@gamil.com |
|
|
Source of Monetary or Material Support
|
| UNIVERSITY COLLEGE OF AYURVEDA KARWAD JODHPUR RAJASTHAN PIN 342037 |
|
|
Primary Sponsor
|
| Name |
Dr Sarvepalli Radhakrishanan Rajasthan Ayurved University jodhpur |
| Address |
Dr. sarvepalli radhakrishnan rajasthan ayurved university,UNIVERSITY COLLEGE OF AYURVEDA, karwad 342037 JODHPUR RAJASTHAN |
| 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 kusum gehlot |
Dr. Sarvepalli Radhakrishnan Ayurved University hospital |
Department of Dravyaguna, room number 12 dravyaguna department,UNIVERSITY COLLEGE OF AYURVEDA JODHPUR RAJASTHAN
Jodhpur
RAJASTHAN |
08058513105
gahlotk42@gamil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of DSRRAU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: HYPERTENSION, (2) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: uchharaktachap, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PIPPALYADI YOG |
1 gram of pippalyadi yog thrice in a day before meal with luke warm water for 60 days |
| Comparator Agent |
SARPAGANDHADI ghan VATI |
1 gram sarpagandhadi ghan vati thrice in a day with luke warm water before meal |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patient having the symptoms raised blood pressure .
patient willing to sign the consent forms.
patient having blood pressure upto 160/100 mmhg. |
|
| ExclusionCriteria |
| Details |
1.Open and randomized clinical age less than 25 years and more than 75 years.
2.patients having blood pressure >160/100mmhg.
3.patient having a history of untreated thyroid
disorder and drug addiction. pregnant women and lactating mother. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in subjective and objective parameters. |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the comparative efficacy of the treatment in both groups. |
60 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
05/01/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This trial will be done for compare the clinical efficacy of pippalyadi yog and sarpagandhadi ghan vati in the management of uccharaktchap .Total 40 patient which are divided in to two groups( 20 patient each),Group A patient will take pippalyadi yog 1 gram thrice in a day and group B patients will take sarpagandhadi ghan vati thrice in a day with luke warm water . at present time hypertension is a common problem .it does not affect only our heart although many other diseases. |