| CTRI Number |
CTRI/2024/06/068843 [Registered on: 13/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessing the effect of Kankola in hypertension |
|
Scientific Title of Study
|
Pharmaco-therapeutic effect of Kankola (Piper cubeba Linn.f.)Phala in the management of Uchcha-raktchap (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 Prachi Goyal |
| Designation |
MD SCHOLAR |
| Affiliation |
Post Graduate Institute of Ayurveda DSRRAU Jodhpur |
| Address |
Department of Dravyaguna Post Graduate institute of Ayurveda DSSRAU Naguar road karwar Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9460754660 |
| Fax |
|
| Email |
gprachigoyal929@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prachi Goyal |
| Designation |
MD SCHOLAR |
| Affiliation |
Post Graduate Institute of Ayurveda DSRRAU Jodhpur |
| Address |
Department of Dravyaguna Post Graduate institute of Ayurveda DSSRAU Naguar road karwar Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9460754660 |
| Fax |
|
| Email |
gprachigoyal929@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajendra Prasad Purvia |
| Designation |
Associate Professor |
| Affiliation |
Post Graduate Institute of Ayurveda DSRRAU Jodhpur |
| Address |
Department of Dravyaguna Post graduate institute of Ayurveda DSSRAUNaguar road karwar Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9782230577 |
| Fax |
|
| Email |
drrajpurvia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate institute of Ayurveda , DSSRAU , naguar road Karwar jodhpur rajasthan india 342037 |
|
|
Primary Sponsor
|
| Name |
Post Graduate institute of Ayurveda , DSSRAU JODHPUR |
| Address |
Department of Dravyaguna , Post Graduate institute of Ayurveda , DSSRAU JODHPUR naguar road Karwar, 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 RAJENDRA PRASAD PURVIA |
Sanjeevani Hospital |
Department of Dravyaguna ,Post Graduate institute of Ayurveda , DSSRAU, Naguar road , Karwar , Jodhpur
Jodhpur
RAJASTHAN |
9782230577
drrajpurvia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. Sarvepalli Radhkrishnan Ayurved University Post Graduate institute of Ayurved 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. Ayurveda Condition: RAKTAVRUTAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kankola, Reference: Kaidev Nighantu, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group 35- 60 years of age.
2. Patient having symptoms of continuous raised blood pressure.
3.Patient having Systolic blood pressure between 140 to 160mm of Hg and Diastolic blood pressure between 90-100mm of Hg. |
|
| ExclusionCriteria |
| Details |
1. Age less than 35 years and more than 60 years of age.
2. Patients having Systolic blood pressure ≤140 and ≥160 mm of Hg and Diastolic blood pressure ≤90
and ≥100mm of Hg.
3. Pregnant women and lactating mother.
4. Patients receiving on anti hypertensive drug.
5. Complicated hypertensive cases e.g. Nephropathy and left ventricular hypertrophy, heart block ,
congestive heart failure, coronary artery disease and retinopathy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in blood pressure will be assessed. |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in
1. RFT/KFT
2. CBC
3. Lipid Profile ( HDL, LDL, VLDL, TG)
4. ECG
|
60 days |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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 Yet Recruiting |
| 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 is an interventional open label single arm trial to evaluate the efficacy of Kankola (Piper cubeba linn) in management of Hypertension . In this study 3gms of Kankola Phala Churna will be given to patients thrice a day with lukewarm water for 60 days. the treatment period will be of 60 days. The follow up period will of 30 days during the trial and 30 days after completion of the trial. |