CTRI Number |
CTRI/2023/05/052858 [Registered on: 18/05/2023] Trial Registered Prospectively |
Last Modified On: |
18/05/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Management of Migraine through Ayurveda |
Scientific Title of Study
|
A Randomized Comparative Clinical Study to Evaluate the Effect of Dashmoola Kwath Nasya and Shigru Taila Nasya along with Mundi Swarasa in the Management of Ardhavabhedaka (Migraine) |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Ashu |
Designation |
Professor |
Affiliation |
Shri Krishna Government Ayurvedic College and Hospital |
Address |
Room No 108 Department of Shalakya Tantra Shri Krishna Government Ayurvedic College and Hospital Kurukshetra
Kurukshetra HARYANA 136118 India |
Phone |
9416553131 |
Fax |
|
Email |
drashukataria@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Ashu |
Designation |
Professor |
Affiliation |
Shri Krishna Government Ayurvedic College and Hospital |
Address |
Room No 108 Department of Shalakya Tantra Shri Krishna Government Ayurvedic College and Hospital Kurukshetra
Kurukshetra HARYANA 136118 India |
Phone |
9416553131 |
Fax |
|
Email |
drashukataria@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Ashu |
Designation |
Professor |
Affiliation |
Shri Krishna Government Ayurvedic College and Hospital |
Address |
Room No 108 Department of Shalakya Tantra Shri Krishna Government Ayurvedic College and Hospital Kurukshetra
Kurukshetra HARYANA 136118 India |
Phone |
9416553131 |
Fax |
|
Email |
drashukataria@gmail.com |
|
Source of Monetary or Material Support
|
Shri Krishna Ayush University Kurukshetra Haryana 136118 |
|
Primary Sponsor
|
Name |
Dr Monika Jangra |
Address |
Shri Krishna Government Ayurvedic College and Hospital Kurukshetra |
Type of Sponsor |
Other [Government Ayurvedic 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 Monika Jangra |
OPD no 54, Shalakya Tantra OPD, Shri Krishna Government Ayurvedic College and Hospital Kurukshetra |
Shri Krishna Ayush University Sector 8 Umri Road Kurukshetra Haryana 136118 Kurukshetra HARYANA |
9050294577
mj4652520@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
IEC |
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 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Sushruth Chikitsa 40, Procedure details: Patient should lie down in supine position then Abhyanga with Tila Taila for 5-7 minutes and then Nadi Swedan for 3 minutes will be done. After this tip of nose should be tilted up by left middle finger or thumb of the physician. One nostril should be closed with the finger of the physician. Then Koshna Sneha in the form of Marsh Nasya with Dashmoola Kwath Nasya in doses of 6-8 bindu will be administered nasally, same procedure should be repeated in another nostril also.) (1) Medicine Name: Dashmoola Kwath Nasya, Reference: chakkradatta 60/42, Route: Nasal, Dosage Form: Kwatha/Kashaya, Dose: 8(drops), Frequency: od, Duration: 35 Days(2) Medicine Name: Mundi Swarasa, Reference: Sharangdhar Samhita Madhyam khand 1/17, Route: Oral, Dosage Form: Swaras/ Juice, Dose: 25(ml), Frequency: bd, Duration: 35 Days | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Sushruth Chikitsa 40, Procedure details: Patient should lie down in supine position then Abhyanga with Tila Taila for 5-7 minutes and then Nadi Swedan for 3 minutes will be done. After this tip of nose should be tilted up by left middle finger or thumb of the physician. One nostril should be closed with the finger of the physician. Then Koshna Sneha in the form of Marsh Nasya with Shigru Taila Nasya in doses of 6-8 bindu will be administered nasally, same procedure should be repeated in another nostril also.) (1) Medicine Name: Shigru Tila Nasya, Reference: Bhav Prakash Guduchyadi Varga page no. 339, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 35 Days(2) Medicine Name: Mundi Swarasa, Reference: Sharangdhar Samhita Madhyam khand 1/17, Route: Oral, Dosage Form: Swaras/ Juice, Dose: 25(ml), Frequency: bd, Duration: 35 Days |
|
|
Inclusion Criteria
|
Age From |
16.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1) Patients with sign and symptoms of Ardhavabhedaka (Migraine with or without aura)
2) Patients those are fit for Nasya Karma according to Ayurveda text
3) Patient willing to register for clinical study |
|
ExclusionCriteria |
Details |
1) Age group <16 years and >60 years.
2) The patient having any systemic illness, like - Diabetes mellitus, Hypertension, Tuberculosis, Hypotension & fever etc.
3) Patients suffering from head injury and other type of headaches except migraine.
4) Patients Contraindicated for Nasya Karma.
5) Pregnant and lactating mothers.
6) Individuals suffering from general debilitating health condition, immunocompromised disease or on immunosuppressive drugs.
7) Patients with alcohol, opioids other drug addiction and using any other systemic drugs which may alter the result of study.
8) Patients not willing to be registered for clinical study
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Centralized |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Change in Subjective Criteria of Migraine |
105 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
Relief in sign and symptoms of Ardhavebhedaka (Migraine)
Decrease in grade of severity of disease
To see changes in subjective criteria of disease |
35 Days |
|
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/ Phase 3 |
Date of First Enrollment (India)
|
01/07/2023 |
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="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Headache is the most common problem experienced by the individuals. Around 40% of individuals worldwide are suffering from migraine. According to IHS (Indian Headache Society), migraine constitute 16% of the primary headache and affects about 10-20% of general population (about 15% male and 6% female are the sufferers of the migraine). About 80% of patients have migraine without aura and 15-20% have migraine with aura. It is more common in women than in men (3:1) and family history is present in more than 60% of cases. Changing hormonal level also play a role. In the global burden of disease survey 2010 Migraine is the 3rd most prevalent and 7th leading cause of disability worldwide. In GBD 2015, it was ranked the third-highest cause of disability worldwide. The community-based prevalence of migraine in India is similar to that observed in other countries except Africa. There is no permanent treatment of migraine in modern therapy. Treatment protocol is not fixed as no unique etiology, pathogenesis and diagnosis criteria is known. Hence there is a need to develop safe, conservative treatment for migraine. This study gives importance to break the Samprapti of the disease. In Ayurveda, the Acharyas have recognized the importance of medicines, especially of the herbal medicines. Single drug treatment was the beginning point in the therapeutic regimen. Total effects of all the ingredients in the formula rather than the action of individual drugs that plays a vital role in therapeutics. According to Acharya Sushruta tridosha is the causative factor for Ardhavabhedaka. Acharya Vagbhata and Charaka described Vata and Vata-Kapha doshas in Ardhavabhedaka. Thus the drug to be selected should mainly have Vata and Kaphahara property. Vata and Vata-Kaphahara properties of Dashmoola and Shigru is the reason behind the selection of drug amongst the medicinal heritage of traditional Indian medicine. Nasya is considered as the best procedure in all Urdhwajatrugata rogas. The Hence in present study, Nasya with Dashmoola Kwath and Shigru Taila is considered. Along with this Mundi Swarasa selected for internal administration which is recommended in Ardhavabhedaka. For this study total 60 patients will be taken, 30 in each group. First group will be given Dashmoola Kwath Nasya along with oral administration of Mundi Swarasa for 35 days. Second group will be given Shigru Taila Nasya along with oral administration of Mundi swarasa for 35 days. |