| CTRI Number |
CTRI/2025/03/083175 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| 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 Open Labelled Controlled Clinical Study To Evaluate The Efficacy Of Manjishthadi Taila Nasya And Anu Taila Nasya Along With Pathyadi Kwath In The Management Of Ardhavabhedaka(Migraine) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaishali |
| Designation |
MS Shalakya Tantra PG Scholar |
| Affiliation |
Institute For Ayurved Studies and Research Faculty of Ayurved, SKAU Kurukshetra |
| Address |
Room no 50 ,Institute for ayurved studies and research, Faculty of Ayurved,Shri krishana AYUSH university, Sector 8 Umri Road, kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
8901120843 |
| Fax |
|
| Email |
vaishaliyadav874@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manoj Kumar |
| Designation |
Associate Professor |
| Affiliation |
Institute For Ayurved Studies and Research Faculty of Ayurved, SKAU Kurukshetra |
| Address |
Room no. 109 PG Dept. of Shalakya Tantra, Institute For Ayurved Studies and Research, Faculty of Ayurved, SKAU Kurukshetra 136118
Kurukshetra
HARYANA
136118
India |
| Phone |
9996310888 |
| Fax |
|
| Email |
drmanojtanwar23@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishali |
| Designation |
MS Shalakya Tantra PG Scholar |
| Affiliation |
Institute For Ayurved Studies and Research Faculty of Ayurved, SKAU Kurukshetra |
| Address |
Room no 50 ,Institute for ayurved studies and research, Faculty of Ayurved,Shri krishana AYUSH university, Sector 8 Umri Road, kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
8901120843 |
| Fax |
|
| Email |
vaishaliyadav874@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies and Research Faculty of Ayurved SKAU Sector 8 Umri Road Kurukshetra Haryana 136118 |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved Studies and Research |
| Address |
Sector 8 Umri Road Kurukshetra Haryana 136118 |
| Type of Sponsor |
Research institution and hospital |
|
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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 Vaishali |
Institute for Ayurved Studies and Research Hospital |
OPD No. 50, Institute for Ayurved Studies and Research Hospital, sector 8 umri road kurukshetra 136118
Kurukshetra
HARYANA
Kurukshetra
HARYANA |
8901120843
vaishaliyadav874@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri krishana AYUSH university Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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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, नस्यम्/ नस्तम् | (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 Manjishthadi Nasya in doses of 8 bindu will be administered nasally, same procedure should be repeated in another nostril also.))
(1) Medicine Name: Manjishthadi Taila nasya, Reference: sahsrayogam Tailaprakarna 50, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 35 Days(2) Medicine Name: Pathyadi Kwath, Reference: Bhavprakash madhyamkhanda Shirorogadhikar 54,pg.no.400, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 50(ml), Frequency: bd, Duration: 35 Days | | 2 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (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 Anu Taila Nasya in doses of 8 bindu will be administered nasally, same procedure should be repeated in another nostril also.))
(1) Medicine Name: Anu Taila Nasya, Reference: Charaka Sutrasthana (5/56-62), Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 35 Days(2) Medicine Name: Pathyadi Kwath, Reference: Bhavaprakash madhyamkhanda Shirorogadhikar 54,pg.no.400, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 50(ml), Frequency: bd, Duration: 35 Days |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age- 18-60 years
2. Patients with sign and symptoms of Ardhavabhedaka (Migraine with or without aura)
will be selected irrespective of Sex, Religion and Profession.
3. Patients those are fit for Nasya Karma according to Ayurveda text.
4.Patient willing to participate and able to provide signed informed consent. |
|
| ExclusionCriteria |
| Details |
1. Patient of age less than 18 years and more than 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. Secondary headache caused by sinusitis, meningitis, brain tumour, encephalitis,
cervical spondylitis etc.
7. Patients with alcohol, opioids other drug addiction and using any other systemic drugs
which may alter the result of study.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
1.Significant improvement in intensity, frequency, duration of headache.
2.Reduction in scoring pattern of sign and symptoms of Ardhavabhedaka(Migraine)
along with nausea, vomiting, photophobia, phonophobia and aura. |
65 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Improvement in mental & physical well being of patient.
2.Improvement in quality of life of patients. |
65 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)
|
02/04/2025 |
| 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
|
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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 constitutes 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 great role. Hence, to find out such unique phenomenon of Ayurveda and to solve the problem of sufferers of Migraine, Ardhavabhedaka (Migraine with and without aura) has been selected for the present study. 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. 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 and permanent treatment for Migraine. Acharya Sushruta has shown Tridosha as the causative factor of Ardhavabhedaka, Acharya Vagbhata and Charaka described Vata and Vata-Kapha. Pathyadi Kwath is mentioned in Bhavaprakash for headache (Shiroroga). The decoction has ingredients having Ushana Virya and Vatashamak properties, which may be useful in management of Ardhavbhedaka. In Ayurveda Nasya therapy has been considered as one of most promising treatment for all the Urdhawajatrugata Vikaras. Nasya Karma involves administration of herbal oil/drug/liquid into nostril which remove the blockages of the nasal pathways, relief mental stress. These effects of Nasya gives significants relief in disease associated with nose and head region such as Ardhavbhedaka (Migraine). Hence these drugs have been selected to evaluate their efficacy in Ardhavbhedaka w.s.r. to Migraine.
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