| CTRI Number |
CTRI/2023/07/055053 [Registered on: 11/07/2023] Trial Registered Prospectively |
| Last Modified On: |
07/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Sarpagandha ghanvati will be given to patients of High blood pressure
|
|
Scientific Title of Study
|
Clinical evaluation of sarpagandha ghanvati in 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 |
Manisha |
| Designation |
PG Scholar |
| Affiliation |
Uttarakhand ayurved university gurukul campus haridwar |
| Address |
Opd 05 department of kayachikitsa uttarakhand ayurved university gurukul campus haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
8546890482 |
| Fax |
|
| Email |
manisha1995tamta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Punita Pandey |
| Designation |
Professor |
| Affiliation |
Uttrakhand Ayurved University Gurukul Campus Haridwar |
| Address |
OPD 05 Department Of Kayachikitsa Uttarakhand Ayurved University Gurukul Campus Haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
9215074978 |
| Fax |
|
| Email |
pandey.punita62@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manisha |
| Designation |
PG Scholar |
| Affiliation |
Uttarakhand Ayurved University Gurukul Campus Haridwar |
| Address |
Opd 05 department of kayachikitsa uttarakhand ayurved university gurukul campus haridwar
Hardwar
UTTARANCHAL
249404
India |
| Phone |
8546890482 |
| Fax |
|
| Email |
manisha1995tamta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttrakhand ayurved University gurukul campus haridwar |
|
|
Primary Sponsor
|
| Name |
MANISHA |
| Address |
OPD 05 PG DEPARTMENT OF KAYACHIKITSA UTTARAKHAND AYURVED UNIVERSITY GURUKUL CAMPUS HARIDWAR |
| 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 MANISHA |
UAU,GURUKUL CAMPUS HARIDWAR |
OPD 05 PG DEPARTMENT OF KAYACHIKITSA UTTARAKHAND AYURVED UNIVERSITY GURUKUL CAMPUS HARIDWAR
Hardwar
UTTARANCHAL |
8546890482
manisha1995tamta@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:I10||Essential (primary) hypertension. Ayurveda Condition: RAKTAVRUTAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Sarpagandha ghan vati , Reference: Siddhayoga sangraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Lukewarm Water ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex with age between 18-70 years
Patients having Systolic Blood Pressure is more than 140 and less than 180 mm of Hg
Patients having Diastolic Blood Pressure is more than 90 and less than or equal to 110 mm of Hg
|
|
| ExclusionCriteria |
| Details |
Patients of either sex below 18 years & above 70 years will be excluded from the study
Patients having Systolic Blood Pressure is more than 180mm of Hg
Patients having Diastolic Blood Pressure is more than 110mmHg
Patients suffering from serious comorbidities like Renal failure, Coronaryartery disease, endocrinal disorder, congestive heart disease
Pregnant woman
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
a) Headache
b) Giddiness
c) Palpitations
d) Breathlessness
e) Insomnia
|
Assessment willl be done weekly for 8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. systolic blood pressure
2. diastolic blood pressure |
Assessment of the patients will be done weekly for 8 weeks |
|
|
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 |
|
Date of First Enrollment (India)
|
17/07/2023 |
| 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="9"
Days="10" |
|
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 is a open label clinical trial to determine the efficacy of sarpagandha ghanvati in hypertension for the age group between 18 to 70 years for 45 days.Study will be conducted at UAU, Gurukul Campus, Haridwar on 40 patients. Assessment will be done on the basis of subjective and objective parameters. Study will be conducted at OPD/IPD level of PG department of Kayachikitsa. Assessment will be done at weekly interval and result obtained will be analyzed using appropriate tests |