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CTRI Number  CTRI/2023/07/055796 [Registered on: 28/07/2023] Trial Registered Prospectively
Last Modified On: 27/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani
Other (Specify) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Treatment of Hypertension (abnormally high blood pressure) with herbal Unani medicine 
Scientific Title of Study   Evaluation of safety and efficacy of Zaranbad (Curcuma zedoaria Rosc.) in Primary hypertension- a randomized standard control trial. 
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 Nehanaz M Donur 
Designation  PG Scholar 
Affiliation  Luqman Unani Medical College Hospital and Research Centre  
Address  Department of Moalajat, Luqman Unani Medical College Hospital and Research Centre, Bijapur, Karnataka

Bijapur
KARNATAKA
586101
India 
Phone  8904314761  
Fax    
Email  donurnehanaz@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Farooqui Shazia Parveen Barkat Ali 
Designation  Assistant Professor 
Affiliation  Luqman Unani Medical College Hospital and Research Centre  
Address  Department of Moalajat, Luqman Unani Medical College Hospital and Research Centre, Bijapur, Karnataka

Bijapur
KARNATAKA
586101
India 
Phone  8147438868  
Fax    
Email  Shaziafarooquinium@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nazim Husain 
Designation  Assistant Professor 
Affiliation  Luqman Unani Medical College HospLital and Research Centre Vijayapura Karnataka 
Address  Department of Moalajat, Luqman Unani Medical College Hospital and Research Centre, Bijapur, Karnataka

Bijapur
KARNATAKA
586101
India 
Phone  9212143572  
Fax    
Email  dr.nazimhusain@gmail.com  
 
Source of Monetary or Material Support  
Research OPD, Luqman Unani Medical College Hospital and Research Center 
 
Primary Sponsor  
Name  Luqman Unani Medical College Hospital and Research Center 
Address  Luqman Unani Medical College Hospital and Research Centre12 Naubag Vijayapura Karnataka 586101  
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 
Nehanaz Donur  Luqman Unani Medical College Hospital and Research Centre  Ground Floor, Room no.9, PG-OPD, Dept. of Medicine, Luqman Hospital, Karnataka, India 586101
Bijapur
KARNATAKA 		 8904314761

donurnehanaz@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee of Luqman Unani Medical College   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Hydrochlorothiazide  in the form of tablets through Oral route dose 25mg once daily with plain water Follow up 1st week 2nd week 3rd week and 4th week In addition, the patients of both groups will be advised to take DASH-diet and also mild to moderate exercise like brisk walk for 30 minutes.  
Intervention  Zaranbad (Curcuma Zedoria Rosc)  in the Form of Capsule through Oral route Dose 1g twice daily with plain water Follow up 1st week 2nd week 3rd week and 4th week Method of preparation Crude Zaranbad will be procured from registered herbalist. then it will be subjected to taxonomical identification by botanist Zaranbad will be cleaned, grinded to make SafÅ«f (fine powder) and sieved through 80 sized mesh Then powder will be filled in capsules  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Diagnosed cases of grade1 hypertension 
 
ExclusionCriteria 
Details  Pregnant and lactating women.
Patients suffering from any other systemic diseases.
Patients suffering from secondary hypertension
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in systolic & diastolic blood pressure  Change in systolic & diastolic blood pressure baseline to end of treatment & every followup  
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life MINICHAL  baseline & after treatment  
 
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 2 
Date of First Enrollment (India)   07/08/2023 
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="1" 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [donurnehanaz@gmail.com].

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 01-07-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Hypertension is characterized by persistently high blood pressure (BP) in the systemic arteries 1,2. BP is commonly expressed as the ratio of the systolic BP (that is, the pressure that the blood exerts on the arterial walls when the heart contracts) and the diastolic BP (the pressure when the heart relaxes)1. According to AHA Hypertension is diagnosed if, when it is measured on two different days, Hypertension is diagnosed when blood pressure is consistently ≥130 and/or ≥80 mm Hg3. Hypertension is a serious medical condition that significantly raises the chances of heart, brain , kidney, and other diseases and is a leading cause of premature death globally, An estimated 1.28 billion individuals aged 30-79 years worldwide have hypertension, most (two-thirds) living in low- and middle-income countries, An estimated 46 % of adults with hypertension are unaware of the condition and 42  adults with hypertention are diagnosed and treated1. Hypertension is classified as either primary (essential) or secondary hypertension, Primary hypertension accounts for âˆ¼ 90% of cases of hypertension and has no detectable cause, whereas secondary hypertension  is caused by a specific underlying condition which include renal, endocrine, and vascular diseases2,4 . Non-modifiable risk factors includes Age, gender, genetic factors and ethnicity ,Modifiable risk factors includes Obesity,excessive salt intake, saturated fat, physical inactivity,  alcohol, environmental stress and other factors5. Early symptoms of hypertension includes chest pain, shortness of breath, palpitations, claudication, peripheral edema, headaches, nocturia and dizziness. Signs and symptoms suggestive of secondary hypertension i.e, organ damage include myocardial infarction , renal artery stenosis, and stroke1,2,5,6. Hypertension is treated with antihypertensive medications either in monotherapy or in Combination therapy, drugs include ACE inhibitors, thiazide diuretics, angiotensin II receptor blockers and calcium-channel blockers 2,5,7. These drugs are able to control the blood pressure but associated with serious side effects such as hyperglycemia, , impotence, depression, vomiting, drowsiness, fatigue, dizziness, diarrhea, loss of taste ,cramps, dryness of mouth,  leucopenia, and constipation8.Although hypertension has not specifically described as such in the classical Unani text, it has been identified by virtue of its clinical symptoms, which primarily match those of the humoral disease “Imtilā ba hasbal-awiyya”9. This condition can be characterized as fullness of vessels with an abnormally high volume of blood7,9. The treatment of this condition is focused on the removal of excessive humour from the body; therefore, therapeutic interventions such as idrār (diuresis) and faá¹£d(venesection), which help to minimise excess humour, can be helpful 5,7, TaskÄ«n-i Qalb (To normalize the heart rate)10TafrÄ«h (Exhilaration) 10Tawsī‘-i UrÅ«q (Dilatation of blood vessels) in case of narrowing of vessels  TaqlÄ«l-i Ghizā (To reduce the quantity of food)11,TahzÄ«l (To reduce the body weight) 10, Islāh-i Nizām-i Hazm (To correct the digestive system)10.There are several single and compound drugs advocated by renowned Unani scholars such as Tukhm-e-Kharpaza (Cucumis milo Linn.), Tukhm-e-Kheyarain (Cucumis sativa),Abresham (Silk coccoon), Sandal Sufaid (Santalum  album), Sankhaholi (Evolvulus alsinoides Linn.) ,Asrol (Rauwolfia serpentina), Ood e Saleeb (Poenia officinalis) etc. and compound drugs such as Qurs Tabasheer Kafoori, Sharbat-e-Nilofar5.
Zaranbad is repeatedly described in classical Unani text for effective treatment of symptoms of hypertension which acts as Mufarriḥ (exhilarant) wa muqawwÄ« qalb(cardiac tonic)12–14, mufattiḥ sudad (deobstruent)13 and mudirr-i bawl(diuretic)14. After extensive search of literature sources on hypertension, it is concluded that safety and efficacy of the selected drug was not evaluated on scientific parameters. Thus, present study has been designed to evaluate the safety and efficacy of Zaranbad in the treatment of hypertension titled “Evaluation of safety and efficacy of Zaranbad (Curcuma zedoaria Rosc.) in Primary hypertension- a randomized standard control trial.”  
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