| CTRI Number |
CTRI/2024/09/073923 [Registered on: 13/09/2024] Trial Registered Prospectively |
| Last Modified On: |
06/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Trial of Herbal Syrup in Hypertension |
|
Scientific Title of Study
|
Efficacy evaluation clinical trial of Anti Hypertensive Herbal Syrup developed by DIBER(DRDO) Haldwani |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prakash Raj Singh |
| Designation |
PI and Asst. Professor |
| Affiliation |
Government Ayurveda College and Hospital |
| Address |
Room No. 15
Department of Kriya Sharir
Government Ayurveda College and Hospital
Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9415228314 |
| Fax |
|
| Email |
prakashrajsingh65@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prakash Raj Singh |
| Designation |
PI and Asst. Professor, |
| Affiliation |
Government Ayurveda College and Hospital |
| Address |
Room No-15
Department of Kriya Sharir
Government Ayurveda College and Hospital
Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9415228314 |
| Fax |
|
| Email |
prakashrajsingh65@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Kumar |
| Designation |
Co-PI and Asst. Professor |
| Affiliation |
Government Ayurveda College & Hospital |
| Address |
Room No-23
Kayachikitsa and Panchakarma
Government Ayurveda College and Hospital
Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9616870871 |
| Fax |
|
| Email |
drajay2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Defence Institute of Bio-Energy Research
Defence Institute of Bio-Energy Research DRDO,
Ministry of Defence, Govt. of India Goraparao, Haldwani, Nainital(U.K.)-263139 |
|
|
Primary Sponsor
|
| Name |
Defence Institute of Bio-Energy Research |
| Address |
Defence Institute of Bio-Energy Research
DRDO, Ministry of Defence, Govt. of India
Goraparao, Haldwani, Nainital(U.K.)-263139 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ajay Kumar |
Government Ayurveda College and Hospital |
OPD no. 8 and 11, Hospital Block
Room No- 23, Administrative Block
Government Ayurveda College and Hospital
Varanasi
UTTAR PRADESH |
9616870871
drajay2000@gmail.com |
| Dr Prakash Raj Singh |
Government Ayurveda College and Hospital |
Room No- 15
Department of Kriya Sharir
Government Ayurveda College and Hospital
Varanasi
UTTAR PRADESH |
9515228314
prakashrajsingh65@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Govt Ayurveda College and Hospital Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I10||Essential (primary) hypertension. Ayurveda Condition: HRUDROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Anti Hypertensive Herbal Syrup, Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients are selected irrespective of sex, occupation, caste, etc.
2.The patients between ages of 20 to 60 years are included in the study.
3.Patients with classical signs and symptoms of Hypertension will be taken for the study.
|
|
| ExclusionCriteria |
| Details |
Subjects associated with systemic illness such as Diabetes, Cancer, CKD.
Patients who leave the treatment in between.
Subjects with anatomical deformity.
Subjects with pregnancy.
Patient not willing to participate.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lowering of Blood Pressure in Hypertensive Patient |
1 Month and 2 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lowering in Lipid Level |
3 Month |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/09/2024 |
| 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 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
|
The present clinical study "Efficacy Evaluation/Clinical Trial of Herbal Product Anti-Hypertensive Herbal Syrup" will be undertaken with the following aims and objectives-
Method of data collection: - Review of Literature will be collected from central library as well as Post Graduate Library, and from Authentic Research Journals, Websites, Digital publications etc. 1.A Clinical survey of patient attending O.P.D & I.P.D of Panchakarma & Kaya Chikitsa Dept. Govt. Ayurvedic College & Hospital, Varanasi will be made and patients fulfilling the criteria will be selected for the study regardless of sex, religion& socioeconomic status. 2.Submission and approval of synopsis through IEC and CTRI. 3.The Drugs required for the clinical study will be provided by DIBER, DRDO.
Selection of Cases: 1.For purpose of clinical trial cases of Hypertension patients will randomly be selected regardless of age, sex, occupation and socio-economic conditions, from Kaya Chikitsa & Panchakarma O.P.D and I.P.D of Govt. Ayurvedic College and Hospital, Varanasi. 2.Careful clinical examination and all necessary lab investigations will be performed as per proforma. 3.After diagnosis is established, the patients will be included for clinical trial. 4.The patients will be asked to stop all the previous medications except the trial medication. |