| CTRI Number |
CTRI/2023/03/050643 [Registered on: 13/03/2023] Trial Registered Prospectively |
| Last Modified On: |
11/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of Herbal medicine in lowering blood pressure in comparison with standard medicine |
|
Scientific Title of Study
|
Clinical assessment of treatment efficacy of herbal formulation in reducing hypertension and to
compare with standard medication. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dattatraya Lakshman Shinde |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth Deemed University,College of Ayurved & Hospital,Pune |
| Address |
Bhrati Vidyapeeth(Deemed to be) University, College of Ayurved and Hospital, Pune 43
Department of Kayachikitsa,
HOD cabin, second floor,
Bharati Ayurved Hospital, Pune 43
Pune
MAHARASHTRA
411043
India |
| Phone |
9890111954 |
| Fax |
|
| Email |
dshinde249@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dattatraya Lakshman Shinde |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth Deemed University,College of Ayurved & Hospital,Pune |
| Address |
Bhrati Vidyapeeth(Deemed to be) University, College of Ayurved and Hospital, Pune 43
Department of Kayachikitsa,
HOD cabin, second floor,
Bharati Ayurved Hospital, Pune 43
Pune
MAHARASHTRA
411043
India |
| Phone |
9890111954 |
| Fax |
|
| Email |
dshinde249@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dattatraya Lakshman Shinde |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth Deemed University,College of Ayurved & Hospital,Pune |
| Address |
Bhrati Vidyapeeth(Deemed to be) University, College of Ayurved and Hospital, Pune 43
Department of Kayachikitsa,
HOD cabin, second floor,
Bharati Ayurved Hospital, Pune 43
Pune
MAHARASHTRA
411043
India |
| Phone |
9890111954 |
| Fax |
|
| Email |
dshinde249@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Innovation Foundation, India, Grambharti, Amrapur, Gandhinagar-Mahudi Road, Gandhinagar 382650, India |
|
|
Primary Sponsor
|
| Name |
National Innovation Foundation India |
| Address |
National Innovation Foundation, Hyderabad |
| Type of Sponsor |
Research institution |
|
|
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 Dattatray Shinde |
BVDU College of Ayurveda and Hospital Pune |
Bhrati Vidyapeeth(Deemed to be) University, College of Ayurved and Hospital, Pune 43
Department of Kayachikitsa,
HOD cabin, second floor,
Bharati Ayurved Hospital, Pune 43
Pune
MAHARASHTRA |
09890111954
dshinde249@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BV(DU)COA-EC, 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, (2) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: VYANAVATAKOPAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Drug - Telmisartan 40 mg | Telmisartan 40 mg OD at bedtime, for 3 months | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: NIF herbal lead , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 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 |
• Age group 18-70 years , Either Sex
• Essential hypertension : Mild (Systolic BP- 140 to 159mm Hg and /or Diastolic BP- 90 to 99 mmHg) and Moderate (Systolic 160- 179mm of Hg / or Diastolic BP- 100-109)
|
|
| ExclusionCriteria |
| Details |
1. History of coronary artery disease, myocardial infarction, stroke, transient ischemic attack, any revascularization procedure, congestive heart failure, or hemodynamically significant carotid or peripheral arterial disease
2. Pregnant / Breast feeding women.
3. Women having hormonal contraception or having no effective birth control measure.
4. Diabetes mellitus type I and II
5. As per the opinion of investigator ,any other Surgical /medical illness not mentioned in the protocol - which may place patients at high risk due to their participation in the study OR may lead to their noncompliance to the protocol.
6. Use of other concomitant medications – adrenergic drugs or steroids that may affect blood pressure.
7. Hypersensitivity to any of the test drug
8. Patients with kidney or liver disease
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| LOWERING OF BLOOD PRESSURE |
• Follow up: Every 7th day for upto 1 month and
every 15th day after one month the patients will
be observed for subjective and objective
parameters will be recorded. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood pressure in normal limits is sustained |
• Follow up: Every 7th day for upto 1 month and
every 15th day after one month the patients will
be observed for subjective and objective
parameters will be recorded.
|
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
15/03/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Based on world health organization (WHO) data, worldwide burden of hypertension is substantial, with an estimated 1 billion individuals affected worldwide and 7.1 million deaths per year attributable to hypertension (Forouzanfar et al., 2017). Although several antihypertensive medications are already available and being widely in use but associated side effects like dizziness, headache, dry cough and sexual dysfunction (Bazzano et al., 2008) persuade development of novel and alternative treatments. The study will be undertaken to assess the efficacy of herbal medication in control of hypertension on mild and moderate clinical patients. The efficacy of herbal medicine will be compared with control drug involving 60 patients each for trial medicine and for control medicine. Thus a total of 120 patients will be part of study. The assessment will be executed by recording of Blood pressure and compare the baseline data with data generated at the end of treatment. The treatment duration of medication will be for a period of 90 days [3 months]. Involvement of allopathic medical practitioner has been included as Co-PI for the research program for selection and usage of standard allopathic drug [Telmisartan] as control. During the course of treatment, Body Mass Index (BMI) will be taken into consideration which is known to have strong linear relationship with hypertension (Landi el at., 2018). Additionally, specific investigations including HbA1C, Renal function test, Lipid Profile, Blood sugar random, and ECG baseline will be conducted. The primary end point referred in the study include relief from symptoms while the secondary end point involve reduction/control of Systolic and Diastolic Blood Pressure. The clinical assessment will be conducted every 7 days for the first month and subsequently for every two weeks during the treatment phase. The gradation of symptoms will be evaluated based on parameters like Shiroruka (Headache), Hrudravtava (Palpitation), Klama (Fatigability), Bhrama (Dizziness), Aruchi (Anorexia), Vibhanda (Constipation). These clinically subjective parameters will be correlated with objective parameters by recording Systolic and Diastolic blood pressure. |