| CTRI Number |
CTRI/2023/01/048980 [Registered on: 13/01/2023] Trial Registered Prospectively |
| Last Modified On: |
06/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of difficulty in staying asleep with Unani medicine Raughan-e-Kadu Shireen |
|
Scientific Title of Study
|
Clinical validation of Unani pharmacopoeial formulation Raughan-e-Kaddu-Shireen in Sahr (Insomnia) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| S/I/RKS/ CLNVAL/CCRUM 20-21, version 01 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Asim Ali Khan |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 502, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
unanimedicine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 507, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
9213511298 |
| Fax |
|
| Email |
ccrum507@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer (Pathology) S-IV |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 516, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
8800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support : 1 Regional Research Institute of Unani Medicine (RRIUM), Patna Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine CCRUM New Delhi |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058 |
| 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 |
| Dr Md Manzar Alam |
Regional Research Institute of Unani Medicine, Patna |
Research OPD Room Sahar (Insomnia), Guzri, Patna City
Patna
BIHAR |
9920245133
manzar.medicine@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Regional Research Institute of Unani Medicine, Patna |
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 |
NIL |
NIL |
| Intervention |
Raughan-e-Kadu Shireen |
1ml of oil to be used topically on scalp and sole with fingers for minimum 10 minutes once at night daily for two weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects with males, females and trans-genders between the age group of 18 to 60 years.
2. Subjects with complaining of insomnia that fulfils the diagnostic criteria of Insomnia Disorder of DSM –V.
|
|
| ExclusionCriteria |
| Details |
1. Patients not fulfilling the diagnostic criteria of Insomnia Disorder of DSM-V.
2. Acute illness, fevers or painful conditions.
3. Known patients of Obstructive sleep apnea syndrome,Central Sleep-Apnea Syndrome, Narcolepsy,Breathing related sleep disorder, Circadian rhythm sleep-wake disorder, parasomnia.
4. Known cases of Restless Leg Syndrome, Periodic Limb Movement Disorder.
5. Alcohol or drug abuse within past six months.
6. Pregnant and Lactating Women.
7. Patients with drug abuse and medication.
8. Known patients of Asthma.
9. Known Patients of Migraine or Headache.
10. Known Drug users of Glucocorticoids.
11. Known cases of Parkinson, Chorea, Epilepsy and Dementia.
12. Known patients of skin diseases like Eczema, Scabies and Psoriasis.
13. Known cases of Chronic Obstructive Pulmonary disease.
14. Known patients of mental diseases.
15. Known patients of Cardiac disease
16. Participation in another study or previous participation in similar study.
17. Subjects who are not willing to take part in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in sign and symptoms of Sahr(Insomnia) including sleepiness during the day, general tiredness, irritability and problem in concentration. Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) will be used for the assessment of efficacy. |
On baseline, 7th and 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
On baseline and 14th day |
|
|
Target Sample Size
|
Total Sample Size="165"
Sample Size from India="165"
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)
|
17/01/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is designed as a single centric open trial in patients with Sahar (Insomnia). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at every week. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be two weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition of Raughan-e-Kadu Shireen | S.No. | Name of the Drug | Scientific Name | Quantity | | 1. | Aab Kadu e DaraazTaaza | Lazinariasiceraria | 4 ltrs | | 2. | Raughan Kunjad | Melissa parviflora | 1kg |
|