| CTRI Number |
CTRI/2024/08/072244 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
06/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Vidangadi Nasya in Ardhavbhedaka(Migraine). |
|
Scientific Title of Study
|
A randomised controlled clinical trail to study the effect of vidangadi nasya in ardhavahedaka with special reference to simple 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 Swarada Ashok Gadekar |
| Designation |
Post graduate student |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Shalakyatantra SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Igatpuri Nashik 422403 Maharashtra India
Nashik
MAHARASHTRA
422403
India |
| Phone |
7620264146 |
| Fax |
|
| Email |
swaradagadekar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kajal Tushar Fiarake |
| Designation |
Associate Professor |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Shalakyatantra SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Igatpuri Nashik 422403 Maharashtra India
Nashik
MAHARASHTRA
422403
India |
| Phone |
9850447661 |
| Fax |
|
| Email |
petalsayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swarada Ashok Gadekar |
| Designation |
Post graduate student |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Shalakyatantra SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Igatpuri Nashik 422403 Maharashtra India
Nashik
MAHARASHTRA
422403
India |
| Phone |
7620264146 |
| Fax |
|
| Email |
swaradagadekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakyatantra SMBT Ayurved college and Hospital Nandi Hills Dhamangaon Igatpuri Nashik 422403 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Swarada Gadekar |
| Address |
SMBT Ayurved College and Hospital Nandi Hills Dhamangaon Igatpurti Nashik 422403 Maharashtra India |
| 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 Swarada Gadekar |
SMBT Ayurved College and Hospital |
OPD No 8 Department of Shalakyatantra SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik 422403 Maharashtra
India
Nashik
MAHARASHTRA |
7620264146
swaradagadekar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT Ayurved College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G430||Migraine without aura. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | avapIDanam, अवपीडनमॠ| (Procedure Reference: Dr Pramod Mandalkar Therapeutic Procedures Of Panchakramna Minor Panchakarma Procedure Chapter Eleven Nasyakarma Page Number Forty Nine Rudra Publication, Procedure details: 1)Snehana and hasta tala swedana of uttamanga.(neck and head region)
2)Patient should lie in upright posture with extended limbs and head
tiled backward .
3)Naysa should be administerd in each nostril by pushing tip of nose
backward.
4)Patient will be ask not to swallow the medicine which was poured ,
avoid movement of head ,expel cough which collected in the throat.
5)Massage will be done over the head , neck , face and shoulder region .
6)Then the patient will be told to gargle the mouth with lukewarm water
many times to cleanse the throat. )
(1) Medicine Name: Vidangadi Nasya, Reference: Vangasen, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 4(drops), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | nAvanam, नावनमॠ| (Procedure Reference: Dr Pramod Mandalkar Therapeutic Procedures Of Panchakramna Minor Panchakarma Procedure Chapter Eleven Nasyakarma Page Number Fifty two Rudra Publication, Procedure details: 1)Snehana and hasta tala swedana of uttamanga.(neck and head region)
2)Patient should lie in upright posture with extended limbs and head
tiled backward .
3)Naysa should be administerd in each nostril by pushing tip of nose
backward.
4)Patient will be ask not to swallow the medicine which was poured ,
avoid movement of head ,expel cough which collected in the throat.
5)Massage will be done over the head , neck , face and shoulder region .
6)Then the patient will be told to gargle the mouth with lukewarm water
many times to cleanse the throat.)
(1) Medicine Name: Goghritmanda, Reference: Astanga Sanghra , Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 4(drops), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a) Patients having the cardinal features of Ardhavabhedaka (Migraine
without aura)
b) Patients aged between 18-60 years.
c) Patients will be included irrespective of sex, religion and caste.
d) Patients fit for Nasya Karma. |
|
| ExclusionCriteria |
| Details |
a) Patients having a history of head trauma and other types of
headaches.
b) Patients having any inflammatory diseases in nose ,PNS ,eyes and ears.
c) Patients with other systemic disorder’s like hypertention ,diabetes
mellitus etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in signs and symptoms of Ardhavabhedaka after administration of Vidangadi nasya |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Where the trial group stands in comparison with control group |
18 months |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
17/08/2024 |
| 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 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
|
Ardha means half side of the head and Bhedaka means
perforating type of pain it is the disease having symptoms of Uttamanga
ardhabhaga sambhedana toda ,bhrama. Ardhavabhedaka can co-relate with migraine
mentioned in allopathic medicine. It is typically unilateral headache affecting
one half of head varied with intensity normally accompanied by nausea and
vomiting. The prevalence of Migraine 12%.Vidang is the drug which is
Vaatkaphaghna and Shirovirechanopag ; therefore for the present study Vidang is
selected and with Vidang Tila with Snigdha gunas and Vaatahara properties is
used. Patients having the cardinal features of Ardhavabhedaka (Migraine without
aura) aged between 18-60 years ,patients fit for Nasya Karma will be included
irrespective of sex, religion and caste, written consent from patient will be
taken prior to study. Computerised generated Sampling technique will be used.
Total 62 number of patients will be selected and divided into two groups, named
as Group A (trial group) and Group B (Control group). Vidangadi Nasya group A (Trial group) with 4 drops OD for 7
days and Goghritamanda Nasya Group B (Control group) with 4 drops OD for 7 days
will be given to the patient. Observations will be done on day 0, day 3, day 5 &
day 7. Result of study will be drawn on the basis of criteria of assessment and
statistical analysis. Discussion will be done on the basis of observations and
result obtained during the treatment. Summary will be drawn and whole thesis
work will be summarized. Conclusion will be drawn strictly on basis of
statistical analysis and will be unbiased. |