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CTRI Number  CTRI/2022/12/048459 [Registered on: 26/12/2022] Trial Registered Prospectively
Last Modified On: 17/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To assess the efficacy of fentanyl and tramadol in post operative pain management and role of habbe shifa in preoperative patients. 
Scientific Title of Study   To Compare Injection Fentanyl and Injection Tramadol For Post Operative Pain In Upper Abdominal Surgeries and role of Habbe Shifa in pre operative medication. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Afeefa Naaz 
Designation  MS scholar 
Affiliation  Aligarh Muslim University 
Address  Department of Jarahat, faculty of Unani medicine, Ajmal Khan Tibbiya College, Aligarh Muslim University Aligarh

Aligarh
UTTAR PRADESH
202001
India 
Phone  8851428104  
Fax    
Email  afeefanaaz19@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Simeen Usmani 
Designation  Assistant professor 
Affiliation  Aliagrh Muslim University 
Address  Department of Jarahat, faculty of Unani medicine, Ajmal Khan Tibbiya College, Aligarh Muslim University Aligarh

Aligarh
UTTAR PRADESH
202001
India 
Phone  8851428104  
Fax    
Email  drehtisham777@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Afeefa Naaz 
Designation  MS scholar 
Affiliation  Aligarh Muslim University 
Address  Department of Jarahat, faculty of Unani medicine, Ajmal Khan Tibbiya College, Aligarh Muslim University Aligarh

Aligarh
UTTAR PRADESH
202001
India 
Phone  8851428104  
Fax    
Email  afeefanaaz19@gmail.com  
 
Source of Monetary or Material Support  
Department of Jarahat, faculty of Unani medicine, Ajmal Khan Tibbiya College, Aligarh Muslim University Aligarh 
 
Primary Sponsor  
Name  Department of Jarahat 
Address  Faculty of Unani medicine, Ajmal Khan Tibbiya College, Aligarh Muslim University Aligarh 
Type of Sponsor  Government medical college 
 
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 
Afeefa Naaz  Ajmal Khan Tibbiya College  Department of Jarahat, Faculty of Unani medicine, Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH 		 8851428104

afeefanaaz19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Faculty of Unani Medicine, Ajmal Khan Tibbiya College, Aligarh Muslim University, Aligarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Habbe shifa and Injection fentanyl  Habbe shifa 2 tablets Hs given before 7 days of surgery and Injection fentanyl 100 mcg for 6 hours post operative given IV through infusion pump for the patient of group A, once only 
Comparator Agent  Habbe shifa and Injection tramadol  Habbe shifa 2 tablets Hs given before 7 days of surgery and Injection tramadol 100 mg for 6 hours post operative given IV through infusion pump for the patient of group A, once only 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Open cholecystectomy
Epigastric hernial repair
Umbilical hernial repair
Age between 18 – 65 years
Both sexes
Patients willing for surgery and spinal anaesthesia 
 
ExclusionCriteria 
Details  Patient of ASA3
Psychiatric patient
Neurological disorder
H/O coagulopathy
Patient refusing for spinal anaesthesia 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Haemodynamic parameters
Pain was checked through VISUAL ANALOGUE SCALE 		 outcome was assessed post operative for first 24hours at every 2 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Need of oxygen
Need of rescue drugs
Nausea & vomiting
Sedation
Surgeon satisfaction
Patient satisfaction 		 outcome was assessed post operative for first 24hours at every 2 hours 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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   N/A 
Date of First Enrollment (India)   28/12/2022 
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   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
The international association for the study of pain define Pain as’ An unpleasant
sensory and emotional experience associated with actual or potential tissue damage
or describe in term of damage. Post operative pain can be divided into acute and
chronic pain. Acute pain is experienced immediately after surgery upto 7 days.
Effective postoperative pain control is an essential need of every surgical procedure
Pain pathway has three components :A first order neurone (cell body in dorsal root
ganglion) which transmits pain from a peripheral receptor to a second order neurone.A
Second order neurone in the dorsal horn of the spinal cord, through axon and
spinothalamic tract crosses the midline to reach thalamus where third neurone through
internal capsule reaches to post central gyros.
Enhanced recovery after surgery (ERAS) protocols introduced in 1997 are the pre
operative care protocols that promote early post surgical recovery.The purpose of this
to reduce post operative complications, patient discomfort and reduces the length of
hospital stay.Persistent post surgical pain (PPP) has a incidence of up to 30-50% and
has negative outcome of quality of life and negative burdens on individuals, family and
society.

Habb (Pill) is the earliest dosage form invented by unani physicians.Habbe Shifa is
widely used in the patients who are addicted to opium. Ingredients of habbe shifa as
per NFUM are tukhme dhatura , rewandchini, zanjabeel and samaghe arabi. Aqueous
and alcoholic extract of habbe shifa produce analgesic anti convulsant and antipyretic
activity.
Tramadol is a phenylpiperione analogue of codeine. It is a nonadrenergic serotonergic
and mild agonism of the opiod receptor i.e 1/10th of morphine. It has a half life of 4-6
hours.Tramadol is a centrally acting analgesic that has minimum respiratory depressant
effect.It also prevents neural toxicity by preventing setonin and norephinephrine uptake
in spinal cord. The most common side effect of this drug are Nausea, Vomiting,
Headache, dizziness, itching and hot flushes.
Fentanyl was one of a series of opioids synthesized in 1960. It is effective as opioid
analgesia with enhanced analgesic activity and potency and lesser side effects than
morphine.Fentanyl is a short acting opioid can be used as both intraoperative and
postoperative analgesia and can be given intravenously.
 
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