| 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
|
|
|
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
|
|
|
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. |