| CTRI Number |
CTRI/2025/04/084716 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
12/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study on patients of Insomnia |
|
Scientific Title of Study
|
Therapeutic evaluation of Neuropharmacological effects of Roghan-e-Banafsha Nasal drops in the patients of Insomnia: An exploratory/ pilot Clinical 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 |
Syed Afzal Hussain |
| Designation |
PI (BUMS Final Prof Student) |
| Affiliation |
Jamia Hamdard |
| Address |
Room no. 5, Dept. of Ain, Uzn, Anaf wa Halaq, Majeedia Unani Hospital, Jamia Hamdard, New Delhi
South
DELHI
110062
India |
| Phone |
8376996940 |
| Fax |
|
| Email |
syedafzalhussain35@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Syed Afzal Hussain |
| Designation |
PI (BUMS Final Prof Student) |
| Affiliation |
Jamia Hamdard |
| Address |
Room no. 5, Dept. of Ain, Uzn, Anaf wa Halaq, Majeedia Unani Hospital, Jamia Hamdard, New Delhi
South
DELHI
110062
India |
| Phone |
8376996940 |
| Fax |
|
| Email |
syedafzalhussain35@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Zehra Zaidi |
| Designation |
HoD |
| Affiliation |
Jamia Hamdard |
| Address |
Dept. of Ain, Uzn, Anaf, Halaq wa Asnan, School of Unani Medical Education and Research, Jamia Hamdard, New Delhi
South
DELHI
110062
India |
| Phone |
9868966508 |
| Fax |
|
| Email |
zehra.zaidi@jamiahamdard.ac.in |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Unani Medicine Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan No.61-65 Institutional Area Opp. D Block Janakpuri New Delhi-110058 (India) |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan No. 61-65, Industrial Area, Opp. D Block, Janakpuri, New Delhi-110058 (India) |
| Type of Sponsor |
Research institution |
|
|
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 |
| Syed Afzal Hussain |
Majeedia Unani Hospital |
Room No. 5, Dept Ain, Uzn, Anaf wa Halaq, Majeedia Unani Hospital, Jamia Hamdard, New Delhi-110062
South
DELHI |
8376996940
syedafzalhussain35@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jamia Hamdard Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G470||Insomnia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Qutur (Nasal Drops) with Unani Medicine for 28 days |
Therapeutic Evaluation of Neuropharmacological Effects of Roghan-e-Banafsha (Viola odorata) Nasal Drops in patients of Insomnia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adults students and patients (OPD & IPD) aged 18-60 years with a diagnosis of insomnia.
Patients of all genders.
Patients who are willing to sign the informed consent form and participate in the trail voluntarily.
|
|
| ExclusionCriteria |
| Details |
Patients with history of severe psychiatric or neurological conditions.
Patients used sedative-hypnotic drugs in the last 4 weeks.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Severity of insomnia will be assessed using Insomnia Severity Index (ISI) |
1st day, 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mizaj (Temperament Assessment) will be assessed using Mizaj Assessment Tool developed by CCRUM |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
23/04/2025 |
| 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="0"
Months="2"
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, characterized by difficulty in initiating or maintaining sleep, affects a significant portion of the population, often leading to various psychological and physical impairments. Sleep (Yaqza) is one of the important factor mentioned in six essential factors (Asbab Sitta Daruriyya) of life, which works throughout the life in every individual Unani medicine offers natural therapeutic options, with Roghan-e-Banafsha (Viola odorata) being traditionally used to treat sleep disorders. This pilot study aims to evaluate the neuropharmacological effects and safety of Roghan-e-Banafsha nasal drops in the management of insomnia. The study will enroll 20 adult patients diagnosed with insomnia. Participants received two drops of Roghan-e-Banafsha nasally before bedtime over a period of four weeks. Efficacy was assessed using the ISI, with results compared at baseline and the end of the intervention. Safety was evaluated through standard pre- and post-treatment investigations. Initial findings suggest that Roghan-e-Banafsha may provide a non-invasive, cost effective alternative to conventional sedatives, improving sleep quality with minimal side effects. This study could contribute to the broader use of nasal delivery systems for herbal remedies in treating neurological conditions like anxiety, depression. Further research with larger sample sizes is recommended to confirm these finding and explore additional therapeutic applications. |