| CTRI Number |
CTRI/2019/06/019755 [Registered on: 19/06/2019] Trial Registered Prospectively |
| Last Modified On: |
18/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of vidang taila Nasya and Goghrut Nasya in Migraine |
|
Scientific Title of Study
|
RANDOMIZED CONTROLLED CLINICAL TRIAL TO STUDY THE EFFICACY OF VIDANG TAILA
NASYA AND GOGHRITA NASYA IN THE MANAGEMENT OF ARDHAVBHEDAK |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pallavi Pandurang Vyavahare |
| Designation |
MS Student |
| Affiliation |
Sumatibhai Shah Ayurved and Hospital |
| Address |
Department of Shalakyatantra
Sumatibhai Shah Ayurved and Hospital hadapsar pune
Hadapsar
Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
7719921145 |
| Fax |
|
| Email |
drpallavivyavhare24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilakshi S Pradhan |
| Designation |
Professor and HOD |
| Affiliation |
Sumatibhai Shah Ayurved and Hospital |
| Address |
Department of Shalakyatantra
Sumatibhai Shah Ayurved and Hospital hadapsar pune
Hadapsar
Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
9423580963 |
| Fax |
|
| Email |
drnspradhan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallavi Pandurang Vyavahare |
| Designation |
MS Student |
| Affiliation |
Sumatibhai Shah Ayurved and Hospital |
| Address |
Department of Shalakyatantra
Sumatibhai Shah Ayurved and Hospital hadapsar pune
Hadapsar
Pune
Pune
MAHARASHTRA
411028
India |
| Phone |
7719921145 |
| Fax |
|
| Email |
drpallavivyavhare24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sumatibhai shah Ayurved and Hospital Hadapsar Pune |
|
|
Primary Sponsor
|
| Name |
Pallavi Pandurang Vyavahare |
| Address |
Sumatibhai shah Ayurved college and hospital
Hadapsar Pune |
| 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 Pallavi Vyavahare |
Sane Guruji Arogya Kendra |
Room no 8 and 9
Department of Shalakyatantra
Sane guruji hospital Hadapsar Pune
Pune
MAHARASHTRA |
7719921145
drpallavivyavhare24@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: G431||Migraine with aura, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GOGHRITA |
Nasya
nasal drops
2 Drops in each nostril
for 7 days |
| Intervention |
VIDANG TAILA |
Nasya
nasal drops
2 Drops in each nostril
for 7 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient suffering from symptoms of Ardhavbhedak
i.e. Ardha Manya, Bhru, Shankha, Karna, Akshi, Lalat Ativedanam and Shastra Arni Nibha and Bhrama
Patient between age group 20 to 60 yrs.
Patient of either gender.
|
|
| ExclusionCriteria |
| Details |
Patients suffering from sinusitis systemic disorders like hypertension and dibetes
Secondary headache caused by meningitis tumor encephalitis and refractive errors
Pregnancy and lactation
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective criteria ( by using Grades and Visual analogues Pain Scale)
Bhrama (giddiness)
Shatra Arni Nibha (Throbbing pain)
Unilateral severe pain affecting neck brow ear and orbital area forehead region
Objective criteria (by Gradation)
1 severity of headache
2 frequency of headache
3 duration of headache
4 Episode of Vomiting
4 Duration of Aura |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Study the concept of Ardhavbhedak and Migraine in details
Study the Nasya Kriyakalpa and its uses indications contra indications complications |
21 days |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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 3 |
|
Date of First Enrollment (India)
|
25/06/2019 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
- Screening of patient of Ardhavbhedak will be done using a purposive sampling method. Followed by random sampling by lottery method, who meets the inclusion criteria, till the desired sample size is achieved.
- 72 Patient of Ardhavbhedak will be purposively selected in OPD/IPD basis irrespective of of gender, economic status, religion, occupation.
- 72 Patient will be allocated randomly into two groups-by Lottery methods.
- Group A (Trial Group): 36 patients will be treated with Vidang Taila Nasya for 7 days Dose: 2 drops (1/2 ml) Group B (Control Group):36 patients will be treated with Goghrita Nasya For 7 days Dose: 2 drops (1/2 ml).
- Criteria for assessment -
| subjective criteria will assess will be assessed with help of scoring pattern, Vas scale Objective criteria will be assess with the help of Grading Pattern | |