| 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
|
|
|
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
|
|
|
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 impairmentâ€. 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«nÄ 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 ‘IlÄj 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 IkhrÄj-i-MawÄd (Evacuation of Morbid Material) and Ta‘dÄ«l-i-MizÄj-i-A‘á¸Ä’ (To Balance the Temperamental State of the Organ) and improves Quwwat-i-MudÄfi’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 Naá¹Å«l with Ravghan-i-Nilofar may be beneficial in the management of Sahar (Insomnia). |