| CTRI Number |
CTRI/2024/06/069379 [Registered on: 24/06/2024] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Massage and Nasal drops with Roghan Kaddu in comparison with tablet Zolpidem in Sleeplessness |
|
Scientific Title of Study
|
Efficacy of Dalk i Layyin (soft massage) and Saut (nasal drops) with Roghan i kaddu in Sahr (Primary Insomnia) A randomised controlled 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 Safia Abbasi |
| Designation |
PG Scholar Department of Ilaj Bil Tadbeer |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Ilaj Bit Tadbeer National Institute of Unani Medicine Kottegepalya Magadi main road Bangalore 560091
Bangalore
KARNATAKA
560091
India |
| Phone |
08962542905 |
| Fax |
|
| Email |
safia.abbasi201995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Abdul Nasir Ansari |
| Designation |
Head of Department |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Ilaj Bit Tadbeer National Institute of Unani Medicine Kottegepalya Magadi main road Bangalore 560091
Bangalore
KARNATAKA
560091
India |
| Phone |
9379165162 |
| Fax |
|
| Email |
abdulnasiransari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Abdul Nasir Ansari |
| Designation |
Head of Department |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Ilaj Bit Tadbeer National Institute of Unani Medicine Kottegepalya Magadi main road Bangalore 560091
Bangalore
KARNATAKA
560091
India |
| Phone |
9379165162 |
| Fax |
|
| Email |
abdulnasiransari@gmail.com |
|
|
Source of Monetary or Material Support
|
| NATIONAL INSTITUTE OF UNANI MEDICINE KOTTIGEPPALYA MAGADI MAIN ROAD BANGALORE 560091 |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
Department of Ilaj Bit Tadbeer National Institute of Unani Medicine Kottegepalya Magadi main road Bangalore 560091 |
| 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 Safia Abbasi |
National Institute of Unani Medicine |
Opd number 28 Department of Ilaj Bit Tadbeer National Institute of Unani Medicine Kottegepalya Magadi main road Bangalore 560091
Bangalore
KARNATAKA |
08962542905
safia.abbasi201995@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Institutional Ethics Committee (IEC) For Biomedical Research |
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 |
| Intervention |
Dalki-i-Layyin and Saut |
Test group will be treated with Dalk-i-Layyin on scalp for 20 minutes and SaÕ›uÌ…á¹ with Roghan-i-kaddu, by instilling 2 drops of oil in each nostril at bed time, daily for 15 days. |
| Comparator Agent |
tablet zolpidem 10mg orally |
Control will be given Tab zolpidem, 10 mg at bed time, orally, daily for 15 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Subjects from 18 to 70 years of age
2 All genders
3 Primary insomnia with a score of 10 or more (moderate to severe insomnia) in the Pittsburgh Sleep Quality Index (PSQI)
4 Willingness to participate in the study
|
|
| ExclusionCriteria |
| Details |
1Subjects less than 18 years and more than 70 years
2 A diagnosed case of a sleep disorder other than insomnia
3 Pregnancy and lactation
4 Psychological treatment of insomnia within the past 6 months
5 Alcohol or drug abuse within past 6 months
6 Known cases of Parkinsonism, chorea, epilepsy, dementia
7 Subjects with uncontrolled systemic diseases
8 Subjects of skin diseases like eczema, scabies and psoriasis
9 Unwillingness or inability to comply the requirements of the protocol
10 Shift workers
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pittsburgh Sleep Quality Index (PSQI) |
At baseline, 2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SF-36 Scoring |
2 weeks |
|
|
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)
|
01/07/2024 |
| 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="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
|
Purpose: Efficacy of Dalk-i Layyin (soft massage) and SaÕ›uÌ…á¹ (nasal drops) with Roghan-i-kaddu in Sahr (Primary Insomnia): A randomised controlled clinical trial
Design: Open-labelled , parallel groups Randomized controlled trial
Intervention: Eligible cases of primary insomnia will be allocated randomly into test and control groups having 20 patients in each one after obtaining a written informed consent. Test group will be treated with Dalk-i-Layyin on scalp for 20 minutes and SaÕ›uÌ…á¹ with Roghan-i-kaddu, by instilling 2 drops of oil in each nostril at bed time, daily for 15 days. Control will be given Tab zolpidem, 10 mg at bed time, orally, daily for 15 days. Patients will be assessed on primary and secondary outcomes parameters after the completion of the treatments and the significant difference between the two groups will be analysed using appropriate statistical tests. p < 0.05 will be considered a significant difference.
Primary outcome: Pittsburgh Sleep Quality Index (PSQI)
Secondary outcome: SF-36 for quality of life |