| CTRI Number |
CTRI/2025/07/091713 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Nutool with Roghan-e-khashkhash in insomnia |
|
Scientific Title of Study
|
Efficacy of nutool-e-raas with roghan-e-khashkhash in insomnia (sahar)-an open labelled interventional clinical trial |
| Trial Acronym |
DSM-IV |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ishaq Ahmad |
| Designation |
PG scholar |
| Affiliation |
State Unani Medical College and hospital himmatganj Prayagraj, UP |
| Address |
ground floor, Department of Ilaj-Bit-Tadbeer (IBT), State Unani Medical College and hospital Himmatganj
Allahabad
UTTAR PRADESH
211016
India
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
6307235831 |
| Fax |
|
| Email |
ishaqahmad4800@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Jamal Akhtar |
| Designation |
Professor |
| Affiliation |
State takmeel ut tib college, lucknow |
| Address |
6th floor, Indira Bhawan, Lucknow-226001
Lucknow
UTTAR PRADESH
226001
India |
| Phone |
8052142175 |
| Fax |
|
| Email |
drjamalakhtar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Ishaq Ahmad |
| Designation |
PG scholar |
| Affiliation |
State Unani Medical College and hospital himmatganj Prayagraj, UP |
| Address |
room no.2, ground floor, department of ilaj-bit-tadbeer, state unani medical college and hospital, himmatganj, prayagraj-UP
Lucknow
UTTAR PRADESH
226001
India |
| Phone |
8052142175 |
| Fax |
|
| Email |
ishaqahmad4800@gmail.com |
|
|
Source of Monetary or Material Support
|
| state unani medical college prayagraj, ministry of AYUSH, U.P. govt,India, PIN No. 211016 |
|
|
Primary Sponsor
|
| Name |
State unani medical college and hospital |
| Address |
Department of Ilaj-Bit-Tadbeer (IBT), State unani medical college
and hospital, Himmatganj,Prayagraj, Uttar pradesh (211016) |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ishaq Ahmad |
State Unani Medical College and HAHRDM Hospital |
department of IBT, State Unani Medical College and HAHRDM Hospital-211016
Allahabad
UTTAR PRADESH |
6307235831
ishaqahmad4800@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
Nutool therapy (irrigation) |
participants will be treated with nutool with roghan e khashkhash for 23 days. There will be total 8 sittings. Each sitting will be of 20-30 minutes on 1, 3rd,
5th, 7th, 11th, 15th, 19th, and 23rd day. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient with age 20 years to 60 years of all gender.
2. Clinically diagnosed Patient having a insomnia severity index (ISI) score (more than 8
- less than 21).
3. Patient who will give consent and able to do follow up.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating women.
2. Patient having any systemic and metabolic diseases.
3. Unstable mentally retarded and bed ridden patient.
4. Patient with history of trauma and accident involving skull.
5. Concomitant skin disease involving the skull like tinea capitis,scalp
psoriasis,etc.
6.Patients on sedative and hypnotic drugs, hormonal therapy or any other
psychosomatic drug.
7. Patients who do not report for follow up and who refuses to join the
study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Insomnia
|
7th, 14th, 23rd Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
QOL (SF-36)
HAQ - health assessment questionnaire |
0 to 23th days |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
18/08/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 is a Latin word derived from insomnia which is composed of ‘in’ means not and ‘somnus’ means sleep which means no sleep . Insomnia is an acute or chronic inability to initiate or maintain sleep adequately at night at least 3 night a week for at least 3 months . An estimated (6%-10%) of the adult population suffer from insomnia. which is more common in women. The prevalence of insomnia is increased with advancing age. It may be due to continuous fluctuation in hormones. it is estimated that 40% of all insomnia patient have a co-existing psychiatric disorder. depression is most common disease due to due to its chronicity and insomnia is associated with substantial impairment in an individual quality of life. In allopathic system of medicine treatment Options for insomnia are pharmacologic treatment as sedative like Triazolam (Halcion) or Zolpidem (Ambien) or rapidly acting drugs are more effective, such as flurazepam, clonazepam, Quazepam (Doral) for patient with persisting insomnia, but these are not curative for insomnia rather these drug may cause side effect like, debilities, loss of libido, laziness, addiction etc, which is again call for an alternative management. Unani physician have been successfully treating insomnia (sahar) through Nutool (irrigation therapy) since ancient times, but scientific documentation is not available. So in the light of aforementioned facts, i am determined to conduct a clinical trial to appraise the efficacy of Nutool (irrigation therapy) in management of Sahar (insomnia). Nutool is a regimenal therapy (Ilaj-bit-tadbeer). and it is a novel method, in which decoction of certain drugs or medicated oils are poured over specific sites at certain height in some specific disease. In unani system of medicine, the treatment of Sahar (insomnia) is the restoration of brain homeostasis through various unani tadbeer (therapies), along with dietary components, mubarrid and murattib advia, among them NUTOOL therapy is one of the most commonly used tadbeer for the management of Sahar . The present study has been designed to evaluate the efficacy of nutool-e-raas (irrigation of head) with Roghan-e-Khaskhash in the management of insomnia |