| CTRI Number |
CTRI/2020/11/028833 [Registered on: 03/11/2020] Trial Registered Prospectively |
| Last Modified On: |
02/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study held to see the effect of intake of nagbala milk decoction in treatment of high blood pressure |
|
Scientific Title of Study
|
Single arm clinical study to evaluate the effect of nagbala kshirpak in management of essential hypertension |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Samkit Shah |
| Designation |
MD Scholar Kayachiktsa |
| Affiliation |
Dr D Y Patil College Of Ayurveda And Research Center |
| Address |
Department of Kayachiktsa
Opd no 5
Dr D Y Patil College Of Ayurveda And Research Center Sant Tukaram Nagar Pimpri
Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9822443636 |
| Fax |
|
| Email |
doctorsamkitshah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Gunvant H Yeola |
| Designation |
Principal and HOD Kayachiktsa |
| Affiliation |
Dr D Y Patil College Of Ayurveda And Research Center |
| Address |
Department of Kayachiktsa
Opd no 5
Dr D Y Patil College Of Ayurveda And Research Center Sant Tukaram Nagar Pimpri
Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9028321955 |
| Fax |
|
| Email |
gunvantayurved@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Samkit Shah |
| Designation |
MD Scholar Kayachiktsa |
| Affiliation |
Dr D Y Patil College Of Ayurveda And Research Center |
| Address |
Department of Kayachiktsa
Opd no 5
Dr D Y Patil College Of Ayurveda And Research Center Sant Tukaram Nagar Pimpri
Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9822443636 |
| Fax |
|
| Email |
doctorsamkitshah@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil College Of Ayurveda And Research Center |
|
|
Primary Sponsor
|
| Name |
Samkit Shah |
| Address |
Dr D Y Patil College Of Ayurveda And Research Center
Sant Tukaram Nagar Pimpri Pune |
| 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 |
| Samkit Shah |
Dr D Y Patil College Of Ayurveda And Research Center |
Kayachiktsa OPD and IPD
Dr D Y Patil College Of Ayurveda And Research Center
Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA |
9822443636
doctorsamkitshah@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: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nagbala kshirpak
Dose 40 ml
Frequency Twice daily
Route of administration Oral
Duration of therapy For 21 days |
Nagbala churna 5 gm
Boiled with 40 ml of cow milk along with 160 ml water reduced to 40 ml
Patient will be asked to sieve it and consumed after it is cooled down
This will be advised to take twice a day for a period of 21 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1)Systolic Blood Pressure: less than 170 mm of Hg more than or equal to 140 mm of Hg.
2)Diastolic Blood Pressure: less than or equal to 110 mm of Hg or More than 90 mm of Hg.
3)Patient willing to enroll in the research & to sign the consent form
|
|
| ExclusionCriteria |
| Details |
1)Patient who have past history of atrial fibrillation, acute coronary syndrome, myocardial infarction, stroke or right ventricular hypertrophy, left ventricular hypertrophy, severe arrhythmia in last 6 months.
2)Symptomatic patients with clinical features of early heart failure.
3)Secondary hypertension.
4)Women who are pregnant and lactating or on estrogen replacement therapy.
5)Alcoholics and drug abusers.
6)Accelerated and malignant hypertension.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Nagbala kshirpaka is effective in the management of essential hypertension.
|
21 days study with 3 follow ups (0,7,14,21 days)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
09/11/2020 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of the study is to see the effectiveness of nagbala kshirpak in management of essential hypertension. The study will be conducted with 40 patients showing signs and symptoms of essential hypertension,they will be administered with nagbala kshirpak twice a day for 21 days and follow up will be done on 7,14& 21 days and conclusion will be drawn on the basis of proper statistical methods |