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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 KahuAsrol,  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)”.

 
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