| CTRI Number |
CTRI/2024/03/064422 [Registered on: 19/03/2024] Trial Registered Prospectively |
| Last Modified On: |
06/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic management of Migraine by using Laghu Sutashekhara rasa(orally) with and without Brihata Dashmoola taila nasya(nasal drops). |
|
Scientific Title of Study
|
EFFICACY OF LAGHU SUTASHEKHARA RASA WITH AND WITHOUT BRIHATA DASHMOOLA TAILA NASYA IN THE MANAGEMENT OF MIGRAINE-AN OPEN LABELLED RANDOMIZED COMPARITIVE 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 |
Smitha G S |
| Designation |
M.S Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
4th floor Department of Shalakya Tantra ITRA Jamnagar
GUJARAT
361008
India
Jamnagar GUJARAT 361008 India |
| Phone |
6282133863 |
| Fax |
|
| Email |
smithagsmkv@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Prof Dr D B Vaghela |
| Designation |
Professor, HOD, ITRA |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
4th floor Department of Shalakya Tantra ITRA Jamnagar
GUJARAT
361008
India
Jamnagar GUJARAT 361008 India |
| Phone |
9825407899 |
| Fax |
|
| Email |
drvaghela@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Prof Dr D B Vaghela |
| Designation |
Professor, HOD, ITRA |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
4th floor Department of Shalakya Tantra ITRA Jamnagar
GUJARAT
361008
India
Jamnagar GUJARAT 361008 India |
| Phone |
9825407899 |
| Fax |
|
| Email |
drvaghela@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda Jamnagar Gujarat |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Institute of Teaching and Research in Ayurveda, Opposite Reliance Mart, Jamnagar 361008 Gujarat India |
| 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 Smitha G S |
Institute of Teaching and Research in Ayurveda |
OPD no-4, Shalakya Tantra department, Institute of Teaching and Research in Ayurveda,Opposite B Division Police Station 361008
Jamnagar
Gujarat Jamnagar GUJARAT |
6282133863
smithagsmkv@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:G439||Migraine, unspecified. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Laghu Sutashekhara Rasa, Reference: Rasa Tarangini Parishista, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -Sukoshna Jala), Additional Information: - | | 2 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Ashtanga Hridaya, Procedure details: 1.Purva Karma:
 Arrangements of the materials & equipment.
 Counselling of the patient.
 Written consent of the patient is mandatory.
 Instruct the patient to lie down in supine position with head and neck in low position.
 Take a few drops of sesame oil on your palm and finger tips and do gentle face and neck massage for 2-3 minutes, then heat treatment (steam) is given over the face and neck.
2.Pradhana Karma:
 After covering the eyes with clean cotton cloth, the phy) (1) Medicine Name: Brihata Dashmoola Taila, Reference: Bhaishajya Ratnavali 65/94-98, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 6(drops), Frequency: od, Duration: 37 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients in the age group 18 to 60 years, presenting with signs and symptoms of Migraine.
Chronicity of the disease up to 10 years.
The diagnosis of the disease shall be done on the basis of clinical manifestations like recurrent attack of headache, mostly unilateral in site, variable in intensity, frequency and duration with or without nausea, vomiting, aura and GI tract symptoms. |
|
| ExclusionCriteria |
| Details |
Age less than 18 years and above 60 years.
Chronicity of the disease more than 10 years will be excluded.
Patients suffering from any chronic debilitating disease, with other neurological pathology, E.N.T. pathology, and cases which require surgical intervention will be excluded from study.
Patients suffering from sinusitis, hypertension, secondary headache caused by meningitis, tumour, encephalitis, cervical spondylitis and refractive errors will be excluded from study.
Patients using any other systematic drugs which may alter the results of study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the subjective criteria accessed. |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prolonged effect of Ayurvedic intervention in the management of Migraine. |
45 days |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| Date of Study Completion (India) |
14/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 of Research: Migraine is a neurological and a primary headache disorder. Globally, it is approximated that 15% of people are affected by Migraine. In modern science, number of medicines like anti-inflammatory, pain killer, NSAIDs etc. have been tried in the management of Migraine, but final answer to its management is yet awaited. Moreover, routine use of these drugs leads to GI tract disturbances. So, there is a great scope of research to find out a safe, potent and cost-effective line of treatment through Ayurveda in the management of Migraine.
Information on the Trial procedure and Drug: In Group A Laghu Sutashekhara Rasa, 500 mg, orally with luke warm water, thrice a day after meal for 45 days along with Brihata Dashmoola taila nasya at a dose of 6-6 drops in each nostril at morning (4 sittings, each sitting of 7 days with an interval of 3 days) will be given. In Group B: Only Laghu Sutasekhara Rasa, 500 mg, orally with luke warm water, thrice a day after meal for 45 days will be given. We assure that we will prepare formulations as per S.O.P in the pharmacy of I.T.R.A.
Description of the process: In present study, participants who will be clinically diagnosed and confirmed cases of Migraine enlisted in inclusion criteria will be enrolled. All participants will be divided into two groups by computer generated randomization technique having minimum of 15 patients in one group. Group A will be given with Laghu Sutashekhara Rasa, 500 mg orally with luke warm water thrice a day after meal along with Brihata Dashmoola taila nasya (4 sittings, each sitting of 7 days with an interval of 3 days) and Group B will be given only with Laghu Sutashekhara Rasa, 500 mg orally with luke warm water thrice a day after meals, for 45 days. Follow-up: After completion of the treatment, the patient will be followed up for 1 month at an interval of 15 days. Side Effects: We will follow closely and keep track of any unwanted effects. We may use some other medicines or stop the usage of drug to decrease the symptoms of the side effects. Results: The efficacy of the therapy will be asssessed on the basis of subjective criteria. Benefits: Project will help us to resolve the research, but future generations are likely to be benefited as to find out proper treatment protocol for the management of Migraine. Collected information from this research project will be kept confidential, all outcomes will be noted in tabular form and appropriate tests will be applied to compare the effect. |