CTRI Number |
CTRI/2017/12/011006 [Registered on: 28/12/2017] Trial Registered Prospectively |
Last Modified On: |
22/12/2017 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Unani |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Effectiveness of Unani Drugs in High Blood Pressure |
Scientific Title of Study
|
A Clinical Study to Evaluate the Efficacy and Safety of Tukhm-i Kahu in the Management of Zaght al-Dam Qawi Lazimi (Essential Hypertension) |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Zareena Aquil |
Designation |
PG Scholar |
Affiliation |
Central Research Institute of Unani Medicine, Hyderabad |
Address |
Deptt. of Moalajat, Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad
Hyderabad ANDHRA PRADESH 500038 India |
Phone |
9346672375 |
Fax |
|
Email |
zarzar.aquil@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Prof Qamar Uddin |
Designation |
Professor & HOD Moalajat |
Affiliation |
Central Research Institute of Unani Medicine, Hyderabad |
Address |
Deptt. of Moalajat, Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad
Hyderabad ANDHRA PRADESH 500038 India |
Phone |
8700027178 |
Fax |
|
Email |
ccrumhqrsnd58@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Taufiq Ahmad |
Designation |
Reader |
Affiliation |
Central Research Institute of Unani Medicine, Hyderabad |
Address |
Deptt. of Moalajat, Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad
Hyderabad ANDHRA PRADESH 500038 India |
Phone |
8858121130 |
Fax |
|
Email |
taufiqamu@gmail.com |
|
Source of Monetary or Material Support
|
Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad, 500038 |
|
Primary Sponsor
|
Name |
Central Research Institute of Unani Medicine |
Address |
Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad, 500038 |
Type of Sponsor |
Research institution and hospital |
|
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 |
Zareena Aquil |
Central Research Institute of Unani Medicine |
Deptt. of Moalajat, OPD no. 2 Ground floor, New OPD block, Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad, 500038 Hyderabad ANDHRA PRADESH |
9346672375
zarzar.aquil@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee CRIUM Hyderabad |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Essential Hypertension (Zaght al-Dam Qawi Lazimi), |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Amlodipine (Oral)
|
Drug : Amlodipine.
Dosage Form: Tablet.
Dose: 1 Tablet (5 mg) per day before breakfast.
Route of Adminstration: Oral
|
Intervention |
Tukhm-i Kahu (Oral)
|
Tukhm-i Kahu (Sachet containing 5 g fine powder).
Dosage Form: Powder.
Dose: 1 Sachet (5 g) BD ½ hr before breakfast and dinner.
Route of Adminstration: Oral
|
|
Inclusion Criteria
|
Age From |
35.00 Year(s) |
Age To |
55.00 Year(s) |
Gender |
Both |
Details |
All subjects will meet the following criteria:
1- Patients of any sex in the age group of 35 to 55 years
2- Patients having Stage-I Hypertension according to JNC-8 (Systolic BP 140-159 and
Diastolic BP 90-99 mmHg) with or without the following symptoms:
3- Suda (Headache)
4- Khafaqan (Palpitation)
5- Kasal (Laziness)
6- Qalaq (Anxiety)
7- Usr al-Tanaffus (Breathlessness)
8- Nabz Mumtali (Pulsus plenus)
9- Clinically stable patients
10- Patients not taking any anti-hypertensive drugs
11- Patients willing to sign the informed consent form
|
|
ExclusionCriteria |
Details |
Patients will be excluded if they meet any of the following criteria:
1- Patient with SBP ≥160 mmHg and DBP ≥100 mmHg
2- Patients of Secondary Hypertension
3- Pregnant and Lactating women
4- Obese subjects – BMI >30
5- Drug Addicts, Alcoholics
6- Patients not willing to give consent
7- Patients not willing to come for follow-up
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Reduction in Systolic and Diastolic BP from baseline to last follow up
|
On 7th 14th 21st 28th 35th and 42nd day from baseline |
|
Secondary Outcome
|
Outcome |
TimePoints |
1-Improvement in Signs and Symptoms of Hypertension
2-Haematological and Biochemical Assessments for Safety
3-Improvement of Quality Life Index
|
On 7th 14th 21st 28th 35th and 42nd day from baseline |
|
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
|
Phase 2 |
Date of First Enrollment (India)
|
01/02/2018 |
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
|
None yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Hypertension is a common lifestyle disorder with a very strong risk factor predilection for cardiovascular diseases. Several surveys in the last two decades have reported a prevalence of 6.1% to 36.35% in men and 2%-39.4% in women in urban areas, and from 3%-36% in men and 5.8%-37.2% in women in rural areas respectively .The prevalence of hypertension increases with age and it is estimated that starting from around 15% -20% in early age, it increases to 75% -80% in individuals above 70 years of age. In conventional medicine, certain classes of antihypertensive drugs such as diuretics, calcium channel blockers, ACE inhibitors and Beta-blockers etc are in vogue with certain degree of adverse effects including hyperkalaemia, metabolic acidosis, gynaecomastia, hypotension etc with some contraindications such as COPD, gout, heart block and renal artery stenosis. Furthermore, some of these medicines are much costly. Hence, the alternative therapies should be explored for the better and safe management of hypertension. In Unani system of medicine, hypertension has been described under the term Imtila and various single and compound Unani drugs have been mentioned for its management such as Tukhm-i Kahu, Asrol, Parsiaoshan, Dawa-us-Shifa, Habb-e-Mudir, Sharbat-e-Buzoori, etc.. Tukhm-i Kahu is one among the best Mudir (Diuretic) Advia. Besides of being Mudir, it also reduces the Hiddat of Khun leading to reduction in Imtila and signs and symptoms associated with hypertension.
Keeping the above facts in
view, it has been planned to conduct a clinical trial entitled “A Clinical
Study to Evaluate the Efficacy and Safety of Tukhm-i Kahu in
the Management of Zaghá¹ al-Dam Qawi Lazimi (Essential
Hypertension)â€.
|