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CTRI Number  CTRI/2025/07/091913 [Registered on: 28/07/2025] Trial Registered Prospectively
Last Modified On: 28/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Venesection in the management of palpitation 
Scientific Title of Study   Clinical Validation of Fasd (Venesection) in the management of Khafqan (Palpitations): A Randomized open label study with standard control 
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 Mohammed Sheeraz Mushtaque Ahmed 
Designation  Research Officer Scientist Level 2 and Reader 
Affiliation  Regional Research Institute of Unani Medicine,Habbak Srinagar 
Address  Regional Research Institute of unani medicine Habbak Srinagar Department of Moalajat OPD No 2

Srinagar
JAMMU & KASHMIR
190006
India 
Phone  9797750472  
Fax    
Email  drsheerazmd@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mohammed Sheeraz Mushtaque Ahmed 
Designation  Research Officer Scientist Level 2 and Reader 
Affiliation  Regional Research Institute of Unani Medicine,Habbak Srinagar 
Address  Regional Research Institute of unani medicine Habbak Srinagar Department of Moalajat OPD No. 2


JAMMU & KASHMIR
190006
India 
Phone  9797750472  
Fax    
Email  drsheerazmd@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mohammed Sheeraz Mushtaque Ahmed 
Designation  Research Officer Scientist Level 2 and Reader 
Affiliation  Regional Research Institute of Unani Medicine,Habbak Srinagar 
Address  Regional Research Institute of unani medicine Habbak Srinagar Department of Moalajat OPD No 2


JAMMU & KASHMIR
190006
India 
Phone  9797750472  
Fax    
Email  drsheerazmd@gmail.com  
 
Source of Monetary or Material Support  
Central Council For Research in Unani Medicine CCRUM New Delhi 61 65 Institutional Area Opposite D Block Janakpuri New Delhi 110058 
 
Primary Sponsor  
Name  Central Council for Research in Unani Medicine CCRUM New Delhi 
Address  No 61 65 Institutional Area Opp D Block Janakpuri New Delhi 110058 India  
Type of Sponsor  Research institution 
 
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 
Dr Mohammed Sheeraz Mushtaque Ahmed  Regional Research Institute of Unani Medicine (RRIUM)  Habbak Srinagar Department of Moalajat Opd no 2
Srinagar
JAMMU & KASHMIR 
9797750472

drsheerazmd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, RRIUM, Srinagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I499||Cardiac arrhythmia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fasd (Venesection)   venesection every 15th day and total four sessions in basilic vein 
Comparator Agent  metoprolol  25mg OD bedtime for 60days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Clinically diagnosed patients of Khafqan (Palpitations)
Patients in age group of 18 to 65 irrespective of gender
Patients who are ready to sign the informed consent, follow the protocol and willing to participate in clinical study voluntarily 
 
ExclusionCriteria 
Details  Known cases of Arrhythmias and any bleeding disorders (Thalassemia Hemophilia Menorrhagia or any blood-dyscrasias)

Moderate to Severe Anemic patients

Viral Infections like STDs (AIDS Hepatitis B & C)

Known case of uncontrolled Diabetes Mellitus & HTN

Patients below 18 years and above 65 years

History of substance abuse: Caffeine Alcohol Drug intoxication

Patient who fails to followup

Patient who fails to give writtenconsent

Known cases of Hyperthyroidism Cardiovascular diseass Renal disease and Liver disease

Pregnant and lactating mother 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
ECG
VAS (Visual Analogue Scale) 
60days 
 
Secondary Outcome  
Outcome  TimePoints 
tachycardia
Hypertension 
60days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   30/08/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
Khafqan or palpitation is haracterized by an awareness of the beating of the heart.Patients commonly describe pounding or fluttering heart beats or reports a sensation that the heart is stopping or skipping beats.In unani system of medicine heart is one of the three fundamental organs of the body.Heart is considered as the cheif of vital organs and palpitation is described as critical for heart ailments.Avicenna in his renowed book Cnon of medicine has mentioned palpitation as follows: Palpitation is an irregular mvement of heart.This may be caused by heart utself, pericardium, neighbouring or associated organs.It ocurs due to humoral deragement, simple morbid temperament, inflammatory conditions, dissolution, extrinsic factors or hypersentivity.
Moderm management first line therapy for symptomatic palpitations is beta blocker or calcium channel blocker.Patients who are refractory to medical therapy or who develop left ventricular dysfunction should undergo catheter ablation of premature ventricular contractions.However there are number of drugs and regimens in unani system of medicine for khafqan which are safe and effective.Unani management includes evacuation if is caused by predominance of humous.Evacuation id done through emesis and purgation if it is caused by gastric involvement.In this respect A study entitled Clinical validation of Fasd (Venesection) in the management of Khafqan (Palpitations): A randamized open labelled study with standard control study has been designed. 
 
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