| CTRI Number |
CTRI/2021/10/037024 [Registered on: 01/10/2021] Trial Registered Prospectively |
| Last Modified On: |
30/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Study on Grade 1 Essential Hypertension and Comparative Evaluation of Habbul Buzoor With Standard Control Drug Telmisartan in its Management. |
|
Scientific Title of Study
|
A Clinical Study on Zightul Dam Qawi Ibtidai (Grade 1 Essential Hypertension)and Comparative Evaluation of Habbul Buzoor With Standard Control Drug Telmisartan in its Management |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SADAF |
| Designation |
PG Scholar |
| Affiliation |
Department of Moalejat AKTCH AMU Aligarh |
| Address |
Department of Moalejat AKTCH AMU Aligarh
Department of Moalejat AKTCH AMU Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7417211521 |
| Fax |
|
| Email |
sadaf68.sk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SADAF |
| Designation |
PG Scholar |
| Affiliation |
Department of Moalejat AKTCH AMU Aligarh |
| Address |
Department of Moalejat AKTCH AMU Aligarh
Department of Moalejat AKTCH AMU Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7417211521 |
| Fax |
|
| Email |
sadaf68.sk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Professor Tabassum Latafat |
| Designation |
Professor Department of Moalejat AKTC |
| Affiliation |
Department of Moalejat AKTCH AMU Aligarh |
| Address |
Department of Moalejat Ajmal Khan Tibbiya College Aigarh Muslim University Aligarh
Department of Moalejat Ajmal Khan Tibbiya College Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8218114385 |
| Fax |
|
| Email |
tabassum94tariq@gmail.com |
|
|
Source of Monetary or Material Support
|
| aligarh muslim university |
|
|
Primary Sponsor
|
| Name |
Deptt of Moalejat Ajmal khan tibbiya college and hospital faculty of medicine AMU |
| Address |
Deptt of Moalejat Ajmal khan tibbiya college and hospital AMU |
| Type of Sponsor |
Other [Aligarh Muslim university] |
|
|
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 |
| sadaf |
Ajmal Khan Tibbiya College |
department of moalejat ajmal khan tibbiya college and hospital aligarh muslim university aligarh 202002
Aligarh
UTTAR PRADESH |
7417211521
sadaf68.sk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Ajmal khan tibbiya College Faculty of Unani Medicine,Aligarh Muslim University,Aligarh |
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | TELMESARTAN 40mg | Telmesartan 40mg will be given once a day for two months | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: HABBUL B UZOOR, Reference: NFUM, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 750(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed patients of Grade 1 (According to WHO/ISH,SBP-140-159 mm of Hg and DBP-90-99 mm of Hg)2 essential hypertension on three consecutive visits under optimal conditions.
Patients of either gender.
Patients in the age group of 18 to 60 years.
No evidence of target organ damage should be present.
Patients not taking any anti-hypertensive drugs prior to state of treatment.
Clinically stable patients.
Those who give written consent.
|
|
| ExclusionCriteria |
| Details |
Patients of severe or malignant hypertension.
Patients of Secondary hypertension.
Patients below 18 years of age.
Pregnant women and lactating mothers.
Patients with unstable systemic disorders like liver,kidney or heart diseases etc.
Patients with Clinical or laboratory evidence of target organ damage.
Terminally ill patients like infectious diseases ,AIDS,Tuberculosis etc.
Smokers and alcoholics.Patients who do not sign informed consent form.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy will be assessed clinically by recording reading of systolic and diastolic blood pressure and relief in symptoms(if present)
|
2 months with every 2 week followup
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
relief in symptoms(if present)
|
2 months with every 2 week followup |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/10/2021 |
| 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
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
this study is randomised open parallel group comparative trial comparing the efficacy of Habbul Buzoor 750 mg twice a day with telmikind H 40mg once a day for 2 months in each group of 50 patients with Hypertension grade 1.the study is conducted in AKTCH AMU Aligarh.improvement in objective parameter will be assisted by measuring blood pressure and in subjective parameters by relief in symptoms. |