| CTRI Number |
CTRI/2023/09/057304 [Registered on: 06/09/2023] Trial Registered Prospectively |
| Last Modified On: |
28/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Vachapippali nasya in migraine |
|
Scientific Title of Study
|
“Randomized Open Clinical Controlled Trial To Evaluate
Efficacy Of Vachapipali Avapid Nasya In Ardhavbhedak With
Special Reference To Migrane â€
|
| 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 Aishwarya Adhikrao Metkari |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
OPD no 2 Netra Rog OPD Ground Floor Dhanvantari Ayurved Hospital
Ashta Tal WalWa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
7888288141 |
| Fax |
|
| Email |
Aishwaryametkari23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata Kate |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
OPD no 2 Netra Rog OPD Ground Floor Dhanvantari Ayurved Hospital
Ashta Tal WalWa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9404701645 |
| Fax |
|
| Email |
dr.sujatakate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujata Kate |
| Designation |
Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
2rd Floor Department of Shalakya Tantra Hon Shri Annasaheb Dange
Ayurved Medical College Post Graduate and Research Center Ashta
Tal Walwa Dist Sangli
MAHARASHTRA
416301
India |
| Phone |
9404701645 |
| Fax |
|
| Email |
dr.sujatakate@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research
Center Ashta |
|
|
Primary Sponsor
|
| Name |
Dr Aishwarya Adhikrao Metkari |
| Address |
OPD no 2 Netra Rog OPD Ground Floor Dhanvantari Ayurved Hospital
Ashta Tal WalWa Dist Sangli
Sangli
MAHARASHTRA
416301
|
| Type of Sponsor |
Other [Self] |
|
|
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 Aishwarya Adhikrao Metkari |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
OPD no 2 Netra
Rog OPD Ground
Floor Dhanvantari
Ayurved Hospital
Ashta Tal Walwa
Dist Sangli
Sangli
MAHARASHTRA |
7888288141
aishwaryametkari23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G998||Other specified disorders of nervous system in diseases classified elsewhere. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Avapid nasya | (Procedure Reference: The nasya procedure is taken from the text of principle & practice of panchkarma (13), Procedure details: Vachapippali avapid nasya (42 patient)
Route of administration- Nostril
DharanKala- 2-3 min in morning
Matra- 6 Bindu in each nostril(Madhyam
matra)
Duration- 7 days )
(1) Medicine Name: vachapippali, Reference: The reference of vachapippali nasya is taking from article of Dr Kiran kumar U and Pradeep Kumar K (4, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 6(drops), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | Avapid nasya | (Procedure Reference: . The nasya procedure is taken from the text of principle & practice of panchkarma (13), Procedure details: Sitomadanphala avapid nasya (42
patient)
Route of administration Nostril
DharanKala 2-3 min in morning
Matra 6 Bindu in each nostril(Madhyam
matra)
Duration 7 days)
(1) Medicine Name: Sitomadanphala, Reference: . The chikitsa of present study is taken from Sushrut samhita Nibandhsangrah commentary (8), Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 6(drops), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. patient diagnosed with Ardhavbhedak ( migraine) with
following symptoms
2. Ardhashirashoola , Hrullas, Prakashasahatva, Shabdasahatva,
Chhardi
3. Patient between the age group 18-50 year Irrespective
Gender, Religion, Occupation, Socioeconomic status will be
selected simple Random sampling technique by Lottery
method for the study
4. Patient with chronicity more than three months
5. Nasyaharya
|
|
| ExclusionCriteria |
| Details |
1. Migraine with aura
2. Patient with depression and psychological disorders
3. Referred pain due to any other disorders
4. Head injury or any brain lesions
5. Trigeminal neuralgia
6. Metabolic and systemic disorders causing headache
7. Pregnancy migraine
8. Menstrual migraine |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Vachapippali Avapid Nasya in
Ardhavbhedak with special reference to migraine |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the efficacy of Vachapippali Avapid nasya with
Sitopalamadanphala Avapid nasya in Ardhavbhedak
2. To review in detail the literature about Ardhavbhedak with special reference to migraine
3. To review in detail the literature about Vachapippali Avapid
nasya
4. To review in detail the literature about Nasya karma
5. To observe side effect of Vachapippali avapid nasya if any |
7 Days |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
15/09/2023 |
| 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 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
|
the most common neurovascular headache which constitutes 16% of
the primary headache and affects 10-20% that is 14.5% of the general
population. the ratio of women and men is 3:1 In Ayurveda has mentioned nasya therapy as the master key for
all urdhavajatrugat vyadhi and need of effective treatment for
Ardhavbhedak.
All shirorogas are due to tridosha prakopa and chiefly due to
vata or vata-kapha .Thus, Ardhavabhedak can be best managed with
Aushadhis having ushna, snigdha, properties. Thus vachapippali yoga
in the form of nasya which is having vatakaphhar properties has been
selected as shodhan therapy in the present study. To evaluate Vachapippali Avapid nasya given in 6 Bindu/nostrils for 7 days
once day in the morning is significantly effective in the management
of Ardhavbhedak .. Patient will be taken from the shalakyatantra OPD and IPD
Patient will be selected simple Random sampling technique by Lottery
method on the basis of Inclusion criteria of assessment. Informed written consent will be taken. Sample size 84 patient are taken. Group A(trial group) 42 patient Vachapippali Avapid nasya given given in 6 Bindu/ nostrils for 7 days OD in morning and Group B(control group)
42 patient Sitopalamadanphala Avapid nasya
given given
in 6 Bindu/ nostrils for 7 days OD
in morning .Treatment duration will be 7days for both group and follow up
On 14th, 21st day. Assessment will be done on the basis of
improvement in symptoms of patients before and after the
treatment. |