| CTRI Number |
CTRI/2024/07/071603 [Registered on: 30/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of Nutool & local application of Arq-e-Ajeeb in the management of Migraine. |
|
Scientific Title of Study
|
A Clinical Study To Evaluate The Efficacy Of Arq-e-Ajeeb And Nutool-e-Raas With Roghan-e- Gul And Roghan-e-Kaddu In The Management Of Shaqiqa (Migraine Without Aura). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohd Sajid |
| Designation |
PG Scholar |
| Affiliation |
State Unani Medical College and Hospital Prayagraj Uttar Pradesh India |
| Address |
Department of Ilaj-Bit-Tadbeer (IBT) State Unani Medical College and Hospital Prayagraj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
9250310826 |
| Fax |
|
| Email |
coolkingsajid@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bushra Aftab |
| Designation |
Reader |
| Affiliation |
State Unani Medical College and Hospital, Himmatganj, Prayagraj, Uttar Pradesh (211016) |
| Address |
Department of Ilaj-Bit-Tadbeer (IBT) State Unani Medical College and Hospital Prayagraj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
8279747882 |
| Fax |
|
| Email |
drbushraaftab@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohd Sajid |
| Designation |
PG Scholer |
| Affiliation |
State Unani Medical College and Hospital, Himmatganj, Prayagraj, Uttar Pradesh |
| Address |
Department of Ilaj-Bit-Tadbeer (IBT) State Unani Medical College and Hospital Prayagraj
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
9250310826 |
| Fax |
|
| Email |
coolkingsajid@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Unani Medical College & Hospital Prayagraj,Uttar Pradesh,India Pin Code-211016 |
|
|
Primary Sponsor
|
| Name |
State Unani Medical College and Hospital, Himmatganj, Prayagraj, Uttar Pradesh (211016) |
| Address |
Department of Ilaj-Bit-Tadbeer (IBT) State Unani Medical College and Hospital Prayagraj Uttar Pradesh India
Pin code-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 Mohd Sajid |
State Unani Medical College |
Department of Ilaj-Bit-Tadbeer (IBT) Room No. 2 Ground Floor
Allahabad
UTTAR PRADESH |
9250310826
coolkingsajid@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: G430||Migraine without aura, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Local application of Arq-e-Ajeeb and Nutool-e-Raas with Roghan-e-Gul and Roghan-e-Kaddu |
1. From day 1 Nutool will be started with Roghan-e-Gul and Roghan-e-Kaddu, 500 ml(250 ml each) of
roghan will be poured slowly and steadily from a height of arm length on the affected
part of the cranium twice a week for one month, then the protocol of intervention of
nutool for next one month once a week (total 12 sittings)
2. Patients will be provided Arq-e-Ajeeb for local application whenever attack of migraine
occurs and patient has to fill daily dairy after every episode.
3. The treatment will be stopped with the 12th sitting (60th day of treatment) of Nutool
therapy. The patients will be followed up thereafter for 15 days as per the planned
follow-up visits to assess the efficacy of the treatment.
4. After completion of the trial, comparisons will be made between pre and post-treatment
values of assessment scales using appropriate inferential statistical tests to evaluate the
efficacy of Nutool-e- Raas and Arq-e-Ajeeb.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed patients with migraine as per ICHD criteria.
2. Willing to fill daily headache diary.
3. Patient willing to sign written informed consent.
4. Patient who do report during follow-up (who follow instructions).
5. No systemic and local pathology.
|
|
| ExclusionCriteria |
| Details |
1. Patients below the age 18 years and above 60 years.
2. Non-Migrainous headache: tension type headache; cluster headache; chronic
paroxysmal or non paroxysmal hemicranias.
3. Familial hemiplegic migraine
4. Any allergy related to drug used in this study.
5. Pregnancy and lactation.
6. Patients with Neuropsychiatric illness.
7. Patients with significant co-morbidity eg. Glaucoma, Trigeminal
neuralgia, cervical spondylosis, Seizures disorders.
8. Patients who do not report for follow up and who refuses to join the study.
9. Patients on analgesic, steroidal and hormonal therapy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.VAS(Visual Analogue scale). |
For 1st month (twice in a week)
For 2nd month (Once in a week) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
MIDAS(Migraine Disability Assessment Scale).
HIT-6(Headache impact test-6). |
1st And Last Days of treatment |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
10/08/2024 |
| 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
|
Shaqiqa (Migraine), the second most common cause of headache, and the most common
headache-related, and indeed neurologic, cause of disability in the world. It is a recurrent
attacks of headache, varied in intensity, frequency and duration; commonly unilateral in
onset, and usually associated with anorexia and sometimes with nausea and vomiting. It has two major clinical subtypes:
1. Migraine without aura (Common Migraine)
2. Migraine with aura (Classical Migraine) Migraine without aura (Common Migraine) which occurs in about 80% to 85% of patients
and migraine with aura (Classical Migraine) which occurs in about 15%to 20% of patients. The attack in classical migraine is consist of four phases : aura phase(neurological
dysfunction), prodromal phase, the headache phase and a post-dromal phase. Common
migraine consists of three phases: prodromal phase, headache phase and post-dromal phase.
Other less common types include Hemiplegic migraine, Retinal migraine, Abdominal
migraine, probable migraine, basilar migraine, chronic migraine etc. Migraine is mainly a familial disorder, and it is estimated that 5% of total population suffer
from migraine. The risk factor (triggers) include glare, bright light, sound, hunger, mental
stress, physical exertion, hormonal fluctuations, lack of or excess sleep, alcohol etc. Usually attacks of migraine commence in late childhood, adolescence and early twenties,
more common in females between 25 to 40 years of age. Migraine is a second most
common cause of headache disorder which affects the near about 12% of general
population, more prevalence in women about 15% and 6% of men. It has high influence on
our society due to its disabling nature,and it reduces quality of life and increases defection in
work. World Health Organization (WHO) listed migraine as the 19th disability cause
worldwide, and it is responsible for 1.4% of life lost due to disability in all years. According
to American Headache Society Evidence in US, 1.2 million peoples visit to emergency
department due to migraine.Thus, it is clear that migraine is one of leading cause of
disability in adults and has high disease burden. Thus effective treatment of migraine is
needed with fewer side effects. Despite having effective treatment for acute migraine
attacks (such as Triptans) . The response rate varies from 44-70%. Some patients do not
get relief by two hours after taking oral migraine medications, and recurrence of headache
within 24 hours of initial dosing is common. In addition these medicines have adverse
effects such as NSAIDs cause dyspepsia and gastrointestinal irritation; Ergotamine may
cause nausea. Triptans which are considered as important medicine for acute migraine
treatment are generally not effective in migraine with aura unless given after the aura is
completed and the headache initiated, recurrence of headache within usual time of course of
an attack occurs in most of the patients. The prophylactic agents available have limited
efficacy and may cause adverse effects and not compatible for long term use. Unani Physicians have successfully treated migraine (which is called Shaqiqa in Unani)
since ancient time without any significant side effects on the basis of principles of Tanqia
Mawad-e- Raddia and Taqwiat-e-Dimagh achieved by using Munzij wa Mushil and Nutool,
Sa’oot wa Zimad. There are multiple single and compound drugs used for the
management of shaqiqa i.e., Ustukhuddus, kishneez, banafsha, zafran, sapistan, khatmi,
ayarij feeqra, itrifal etc while Ilaj Bit tadbeer is a method of treatment in which some
external methods and measures are used to cure the disease without the help of internal
medicine. Keeping this in view, a study planned to evaluate the efficacy of Ilaj-bittadbeer in management of migraine using Nutool-e-Raas and local application of some
Unani formulation of drugs. The goal of managing migraine is to reduce migraine frequency,
severity and disability and to improve the quality of life.
Therefore we have planned to conduct a clinical study entitled as “A Clinical Study to
evaluate the efficacy of Arq-e-Ajeeb and Nutool-e-Raas with Roghan-e-Gul and
Roghan-e-Kaddu in the managementof Shaqiqa (Migraine without aura). |