| CTRI Number |
CTRI/2024/10/075060 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
07/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Compare the effects of Polyherbal Unani formulation with a standard control in the Management of Migraine without Aura |
|
Scientific Title of Study
|
A Clinical Study on Migraine without Aura (Shaqeeqa) and its Management with Polyherbal Formulation- A Randomized Standard 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 |
Shaziya Siddiqui Niyaz Ahmed |
| Designation |
MD Scholar Unani |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Moalajat, Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi
Central
DELHI
110005
India |
| Phone |
8767123438 |
| Fax |
|
| Email |
shaziyaisrare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naseem Akhtar Khan |
| Designation |
Professor and Supervisor |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Moalajat, Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi
Central
DELHI
110005
India |
| Phone |
9810815997 |
| Fax |
|
| Email |
drkhannaseem.akhtarkhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shaziya Siddiqui Niyaz Ahmed |
| Designation |
MD Scholar |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Moalajat, Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi
Central
DELHI
110005
India |
| Phone |
8767123438 |
| Fax |
|
| Email |
shaziyaisrare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi-110005 India |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Moalajat, Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi-110005 India |
| 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 Shaziya Siddiqui Niyaz Ahmed |
Ayurvedic and Unani Tibbia College Hospital |
Department of Moalajat, Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi-110005
Central
DELHI |
08767123438
shaziyaisrare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ayurvedic and Unani Tibbia College and Hospital 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 |
Extract of Unani Polyherbal formulation- Ustukhuddus (Lavandula stoechas)100mg, Kishneez khushk (Coriandrum sativum)50mg, Filfil siyah (Piper nigrum)50mg, Tukhm-e-kahu (Lactuca sativa)100mg, Afteemoon (Cuscuta reflexa)50mg, Bisfaij (Polypodium vulgare)50mg, Asgandh (Withania Somnifera)50mg, and Shankhpushpi (Evolvulus alsinoides)50mg-filled in capsule form. |
1 capsule of 500mg twice a day orally with plain water for 6 weeks. |
| Comparator Agent |
Propranolol in tablet form |
1 tablet of 40 mg twice a day orally with plain water for 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient willing to participate in the study and sign the informed consent form.
2.Patients between the age of 18 and 65 years of either sex.
3.Diagnosed cases of migraine based on ICHD-3 criteria. |
|
| ExclusionCriteria |
| Details |
1.Patients of psychotic and neurotic disorder.
2.Patients taking Anti-migraine, Anti-epileptic, Anti- Psychotic, Anti-Depressant, Sedative and Hypnotic medications.
3.Patients with refractive errors.
4.Patients suffering from eye disease, otitis media, sinusitis, pharyngitis, gingivitis,rhinitis, and tonsillitis.
5.Pregnant and lactating women.
6.Renal & hepatic insufficiency and malignancy.
7.Diagnosed cases of Malignant Hypertension and Diabetes mellitus.
8.Patients with Bradycardia or Hypotension.
9.Diagnosed cases of obstructive pulmonary disease like COPD or Asthma.
10.Patients with neck muscle and cranial bones pain. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the safety and efficacy of the proposed Unani Polyherbal Formulation on scientific parameters.
2.To compare the results of Polyherbal Unani Formulation with the standard control in the treatment of Migraine in respect of safety and efficacy. |
1.To evaluate efficacy:
a. Assessment of subjective parameters at base line, 10th, 20th, 30th, and 42nd Day.
b. Assessment of Migraine disability at baseline and after 6 weeks.
2.To evaluate safety:
Haemogram, LFT, KFT at base line, 10th day and after 6 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Unani Polyherbal Formulation on quality of life of the patient (QOL). |
Assessment of Quality of life of patient at baseline and after 6 weeks. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
21/10/2024 |
| 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 Applicable |
| 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
|
This study is a randomised, parallel group, active control clinical trial to evaluate the efficacy and safety of the aqueous extract of Unani polyherbal formulation in the management of Migraine without aura and to Compare it’s efficacy with a standard drug. Migraine headaches can be so severe that it can interfere with person’s daily activities and is associated with a wide range of comorbidities, which range from stress and sleep disturbances to anxiety, depression and even suicide. Migraine worsens the quality of life of individuals and place a significant burden on society.
Moreover, the conventional medical treatment of migraine is linked to large number of side effects, which cause dependance and drug withdrawal symptoms. In contrast to this, a large number of single herbs, compound drugs and regimenal therapies in Unani System of Medicine have been found to be effective in the management of migraine related symptoms without observation of significant side effects and are in clinical practice from many centuries. However, the safety and efficacy of these drugs have not been evaluated on scientific parameters. Hence, there is a need to develop a safe, efficacious and economical drug on modern scientific parameters from the herbal treasury of Unani medicine for the treatment of Migraine. The purpose of this study is to provide a safe and effective drug for managing migraine and to compare its efficacy with a standard drug. |