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CTRI Number  CTRI/2026/01/102036 [Registered on: 27/01/2026] Trial Registered Prospectively
Last Modified On: 23/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Single Arm Study 
Public Title of Study   A Study on the Effectiveness of a Unani Herbal Formulation with Roughan-e-Kishneez in the Management of Insomnia 
Scientific Title of Study   Evaluation Of Efficacy And Safety Of Compound Unani Formulation Along With Roughan-E-Kishneez In The Management Of Sahr (Insomnia Disorder): A Single-Arm Clinical Trial 
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 Ayesha Siddiqua 
Designation  PG scholar 
Affiliation  Government Nizamia Tibbi College 
Address  Department of Moalajat op room no 122 green building Government Nizamia tibbi college and general hospital charminar

Hyderabad
TELANGANA
500002
India 
Phone  7731986460  
Fax    
Email  ayesha161014@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mohammed Ahsan Faroqui 
Designation  Professor and HOD  
Affiliation  Government Nizamia Tibbi College 
Address  Department of Moalajat op room no 122 green building Government Nizamia tibbi college and general hospital charminar

Hyderabad
TELANGANA
500002
India 
Phone  9849139356  
Fax    
Email  dr.faroqui@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ayesha Siddiqua 
Designation  PG Scholar 
Affiliation  Government Nizamia Tibbi College 
Address  Department of Moalajat op room no 122 green building Government Nizamia tibbi college and general hospital charminar

Hyderabad
TELANGANA
500002
India 
Phone  7731986460  
Fax    
Email  ayesha161014@gmail.com  
 
Source of Monetary or Material Support  
Government Nizamia Tibbi College and Hospital 
 
Primary Sponsor  
Name  Government Nizamia Tibbi College and Hospital  
Address  Department of Moalajat op room no 122 green building Government Nizamia tibbi college and general hospital charminar Hyderabad Telangana 500002 India 
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 Ayesha Siddiqua  Government Nizamia Tibbi College and Hospital  Department of Moalajat op room no 122 green building
Hyderabad
TELANGANA 
07731986460

ayesha161014@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, GNTC,Hyderabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F510||Insomnia not due to a substance orknown physiological condition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable   Not Applicable  
Intervention  Topical- Roughan-e-Kishneez Oral- Herbal formulation  Topical- Roughan-e-Kishneez head massage one time at night, Oral- Badranjboya(Melissa officinalis L.)-7gms, Khuzama(Lavandula angustifolia Mill.)- 3gms, Sufoof 5gm BD with water.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients diagnosed with insomnia disorder as per ICSD-3 TR criteria.
Patients with score of (8-21) in insomnia severity index (I.e., mild to moderate)
Pittsburgh sleep quality index (PSQI) global score more than 5 up to 15.
Ability and willingness to provide written informed consent and willingness to adhere to the treatment protocol. 
 
ExclusionCriteria 
Details  Patients with other sleep disorders (narcolepsy, parasomnias, circadian rhythm sleep disorder. Sleep related breathing disorder (OSA, RLS).
Patients with history of substance abuse/use.
Patients with diagnosed other psychiatric and neurological disorders (epilepsy, Parkinson’s, major depressive disorder, bipolar disorder).
Patients with current use of hypnotic medications in the last 2 weeks.
Patients with chronic pain conditions and medical illnesses that significantly impair sleep. (arthritis, CVA, renal failure, liver diseases, COPD, uncontrolled HTN etc.).
Pregnant and lactating women.
Patients with H/O participation in other study within last 2-3 months. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
A reduction in 6 points in ISI will be considered significant.  10th, 20th, 30th day 
 
Secondary Outcome  
Outcome  TimePoints 
A reduction in 3 points will be considered clinically meaningful.  10th, 20th, 30th day 
 
Target Sample Size   Total Sample Size="35"
Sample Size from India="35" 
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 3 
Date of First Enrollment (India)   09/03/2026 
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  
Insomnia a prevalent sleep disorder affecting 12-16% of the population globally with 33% prevalence among Indian adults, is defined as difficulty in initiating and maintaining sleep, is a growing public health concern affecting quality of life and risk of mental and physical health issues. Current treatments, though effective, provide temporary relief but often cause dependance. Unani medicine offers a holistic approach to insomnia, viewing it as “Sahr” caused by imbalance of humors, particularly the predominance of HARARAT and YABUSAT (heat and dryness) in the brain. Unani formulation with badranjboya (Melissa officinalis L.) & khuzama (Lavandula angustifolia Mill.) along with Roughan-e-kishneez are traditionally used to promote restful sleep. Given the historical textual evidence and emerging preclinical studies supporting their sedative, hypnotic and anxiolytic properties, there is a scientific rationale to systematically evaluate the efficacy and safety of Unani interventions in patients with insomnia. This study aims to bridge classical Unani knowledge with modern clinical research, providing evidence-based validation for these traditional therapies.
 
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