| 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
|
|
|
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
|
|
|
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. |