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CTRI Number  CTRI/2025/05/086674 [Registered on: 09/05/2025] Trial Registered Prospectively
Last Modified On: 07/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical Study To Conduct The Effect of Two Drugs Raughan-e-kahu and Raughan-e-kaddu In Patients Of Sahr (Insomnia) In Individual Of Different Temperament  
Scientific Title of Study   To Study The Sahr (Insomnia) In Individual Of Different Temperament And Efficacy Of Raughan-e-kahu and Raughan-e-kaddu In It: A Comparative Study  
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 Mohd Mahmood Farooqui  
Designation  pg scholar  
Affiliation  Govt nizamia tibbi college and hospital  
Address  Opd-6 dept of kulliyate tib Govt nizamia tibbi college and hospital Charminar Hyderabad

Hyderabad
TELANGANA
500002
India 
Phone  9848140117  
Fax    
Email  mahmoodfarooqui98@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohd yousuf uddin  
Designation  Guide and HOD 
Affiliation  Govt nizamia tibbi college and hospital  
Address  OPD 6 dept of kulliyate tib Govt nizamia tibbi college and hospital Charminar Hyderabad

Hyderabad
TELANGANA
500002
India 
Phone  9912904786  
Fax    
Email  yousufmohd96@gmail.cpm  
 
Details of Contact Person
Public Query  
Name  Dr Mohd Mahmood Farooqui  
Designation  Pg scholar  
Affiliation  Govt nizamia tibbi college and hospital  
Address  OPD 6 dept of kulliyate tib Govt nizamia tibbi college and hospital Charminar Hyderabad

Hyderabad
TELANGANA
500002
India 
Phone  9848140117  
Fax    
Email  mahmoodfarooqui98@gmail.com  
 
Source of Monetary or Material Support  
Govt nizamia tibbi college and hospital charminar hyderabad 500002 telangana  
 
Primary Sponsor  
Name  PG department of kulliyate tib  
Address  OPD-6 Govt nizamia tibbi college and hospital Charminar hyderabad 500002 telangana Hyderabad  
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 
Dr Mahmood Farooqui   Govt nizamia tibbi college and hospital   OPD-6 dept of kulliyate tib Govt nizamia tibbi college and hospital charminar hyderabad
Hyderabad
TELANGANA 		 9848140117

mahmoodfarooqui98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G470||Insomnia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL  
Comparator Agent  Raughan-e-kaddu   Medicine name:kaddu Reference:qarabadeen majeedi Route: locally Dosage:4-6ml applied locally on scalp at night Duration 45 days  
Comparator Agent  Raughan-e-kahu   Medicine name :kahu Reference:qarabadeen majeedi Route: locally Dosage:4-6ml applied locally on scalp at night Duration:45 days 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patient of both sex
Patient age between 20 and 50
Patient who fullfill diagnostic criteria of Insomnia (Insomnia Severity Index Scale) 
 
ExclusionCriteria 
Details  Lesser than 20 and greater than 50
Known case of psychiatric disorders,anxiety,epilepsy,parasomnia,asthama,obstructive sleep apnea.
alcohol abuse .
pregnant and lactating women
Patients of heart and kidney diseases
veneral diseases
history of trauma and head injury
Patients having any malignancies 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction of symptoms in participants after 45 days of treatment within 3 follow-ups by given drugs   Reduction of symptoms in participants after 45 days of treatment within 3 follow-ups by given drugs  
 
Secondary Outcome  
Outcome  TimePoints 
The Efficacy Of Two drugs participants overall well-being
The Incidence of any adverse effects during the course of treatment  		 The Efficacy Of Two drugs participants overall well-being
The Incidence of any adverse effects during the course of treatment  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   20/05/2025 
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="6"
Days="0" 
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 - NO
Brief Summary   This open labelled clinical trials aims to assess the Efficacy Of Raughan-e-kahu and Raughan-e-kaddu In the management of Insomnia In Patients Of Different Temperament .
A total of 80 participants in which 2 groups: Group -A(40) and Group-B(40)
Having symptoms of Insomnia will be enrolled .
The participants will receive 4-6 ml of Raughan-e-kahu and Raughan-e-kaddu apply locally on scalp at night with duration of 45 days.
The primary objective is to evaluate the potential impact of Raughan-e-kahu and Raughan-e-kaddu on participants of different temperament and to know the incidence of disease.
 
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