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CTRI Number  CTRI/2024/03/063687 [Registered on: 06/03/2024] Trial Registered Prospectively
Last Modified On: 05/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Other 
Public Title of Study   A clinical study to evaluate the efficacy and safety of irrigation therapy with Medicated Unani Oil in the management of Insomnia 
Scientific Title of Study   A randomized parallel-group single-blinded vehicle-controlled clinical study to evaluate efficacy and safety of Naá¹­Å«l (Irrigation therapy) with Ravghan-i-Nilofar in Sahar (Insomnia) 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Meraj 
Designation  PG Scholar 
Affiliation  Hakim Syed Ziaul Hasan Government/Autonomous Unani Medical College and Hospital Bhopal, (M.P.) 
Address  Government Unani Medical College and Hospital Ayush Campus Nehru Nagar Kollar Bypass road, Kaliyasot Dam, Bhopal, Madhya Pradesh 462003

Bhopal
MADHYA PRADESH
462003
India 
Phone  7408601426  
Fax    
Email  meraj786786.mk@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abdul Rehman MI  
Designation  Assistant Professor 
Affiliation  Hakim Syed Ziaul Hasan Government/Autonomous Unani Medical College and Hospital Bhopal, (M.P.) 
Address  Government Unani Medical College and Hospital Ayush Campus Nehru Nagar Kollar Bypass road, Kaliyasot Dam, Bhopal, Madhya Pradesh 462003

Bhopal
MADHYA PRADESH
462003
India 
Phone  7879794103  
Fax    
Email  drarehman80@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Meraj 
Designation  PG Scholar 
Affiliation  Hakim Syed Ziaul Hasan Government/Autonomous Unani Medical College and Hospital Bhopal, (M.P.) 
Address  Government Unani Medical College and Hospital Ayush Campus Nehru Nagar Kollar Bypass road, Kaliyasot Dam, Bhopal, Madhya Pradesh 462003

Bhopal
MADHYA PRADESH
462003
India 
Phone  7408601426  
Fax    
Email  meraj786786.mk@gmail.com  
 
Source of Monetary or Material Support  
Hakim Syed Ziaul Hasan Govt./(Auto)Unani Medical College & Hospital and Madhya Pradesh Medical Science University Jabalpur 
 
Primary Sponsor  
Name  Hakim Syed Ziaul Hasan Govt./(Auto)Unani Medical College & Hospital 
Address  akim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Nehru Nagar Kollar Bypass road, Kaliyasot Dam, Bhopal, Madhya Pradesh 462003 
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 
Dr Meraj  Hakim Syed Ziaul Hasan Government/Autonomous Unani Medical College and Hospital   OPD No. 7 Department of Ilaj Bit Tadbeer Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Nehru Nagar Kollar Bypass road, Kaliyasot Dam, Bhopal, Madhya Pradesh 462003
Bhopal
MADHYA PRADESH 
7408601426

meraj786786.mk@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee Hakim Syed Ziaul Hasan Government Unani Medical College   Approved 
Institutional Ethics Committee Hakim Syed Ziaul Hasan Government Unani Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F068||Other specified mental disorders due to known physiological condition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Naá¹­Å«l (IRRIGATION THERAPY)  Test Group will be treated by Naá¹­Å«l (IRRIGATION THERAPY) with Ravghan-i-Nilofar 1 Litre for 20 minutes in each sitting for 3 weeks 
Comparator Agent  Naá¹­Å«l (IRRIGATION THERAPY)  Vehicle-Control Group will be treated by Naá¹­Å«l with Ravghan-i-Kunjad 1 Liter for 20 minutes in each sitting for 3 weeks 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients have an Insomnia Severity Index between
8-21.
2. Patient willing to participate in the study 
 
ExclusionCriteria 
Details  1. Pregnant & lactating women.
2. Severe co-morbid patients.
3. Severe psychotic patients.
4. Patients who will be unwilling to participate in the study 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Insomnia Severity Index (ISI)  Baseline (BL), 3rd day, 5th day, 8th day, 13th day and 21st day 
 
Secondary Outcome  
Outcome  TimePoints 
Trying to provide a Standard Operative Procedure (SOP)  Baseline and 21st day 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   12/03/2024 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   Insomnia is defined as “a persistent difficulty with sleep initiation, duration, consolidation, or quality that occurs despite adequate opportunity and circumstances for sleep, and results in some form of daytime impairment”. Various studies conducted worldwide have revealed that the prevalence of insomnia is 10%-30% of the population, some even as high as 50%-60%. Insomnia is more common in women, older persons and those who are struggling financially. 

Insomnia is described as Sahar in the Unani system of Medicine which is characterized by Sleeplessness or Excessive Awakening. 

In Conventional Medicine, several antidepressant and hypnotic drugs are frequently used for the treatment of Insomnia like tricyclic antidepressants (Doxepin), serotonergic antidepressants (Dapoxetine) hypnotic drugs (Triazolam, Temazepam, Flurazepam, Alprazolam, Clonazepam and Lorazepam). These drugs have many side effects, especially addiction.). 

Researchers are trying to resort to natural treatment because of the present side effects scenario. Unani Medicine has become valuable because Sahar has been successfully treated since ancient times without noticeable adverse effects on the body. 

Naá¹­Å«l (Irrigation Therapy) with oils or decoction of various herbs has been already employed in the treatment of Sahar successfully by ancient Unani Physicians. Ibn SÄ«nā recommended that the use of Naá¹­Å«l especially with Ravghan-i-Nilofar is beneficial in the management of Sahar. 

Naá¹­Å«l (Irrigation Therapy) is a classical and effective therapy in ‘Ilāj bi’l TadbÄ«r which is described as the pouring or dripping of medicated decoction or warm water on desired organs. Naá¹­Å«l accelerates the processes of Ikhrāj-i-Mawād (Evacuation of Morbid Material) and Ta‘dÄ«l-i-Mizāj-i-A‘ḍā’ (To Balance the Temperamental State of the Organ) and improves Quwwat-i-Mudāfi’at (Defence Mechanism of Body). This produces essential Neurological, Psychological, and Pharmacological benefits for several disorders. It also enhances local absorption of the medicine which helps to get desired actions. 

Based on the above discussions, it is hypothesized that Naṭūl with Ravghan-i-Nilofar may be beneficial in the management of Sahar (Insomnia).
 
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