| CTRI Number |
CTRI/2022/02/040324 [Registered on: 15/02/2022] Trial Registered Prospectively |
| Last Modified On: |
10/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to see the effect of some Ayurvedic formulation in the treatment of headache which involves pain at eye, eyebrow, forehead,etc |
|
Scientific Title of Study
|
Clinical Trial To Evaluate The Efficacy Of Bhringaraja Swarasadi Siddha Taila Nasya In The Management Of Suryavarta. |
| 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 Hemant Vishwakarma |
| Designation |
MS Scholar Shalakyatantra (Ayurved) |
| Affiliation |
Mams Sumatibhai Shah Ayurved Mahavidhyalay, Hadapsar, Pune |
| Address |
OPD NO. 8, Department of Shalakyatantra, Sane Guruji Arogya
Kendra, Malwadi road,
Hadapsar, Pune
MAHARASHTRA
411028
India
Pune
MAHARASHTRA
411028
India |
| Phone |
9920484854 |
| Fax |
|
| Email |
pearl.vishwakarma1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF DR MRS NILAKSHI S PRADHAN |
| Designation |
H.O.D. Shalakyatantra |
| Affiliation |
Mams Sumatibhai Shah Ayurved Mahavidhyalay, Hadapsar, Pune |
| Address |
OPD NO. 8, Department of Shalakyatantra, Sane Guruji Arogya
Kendra, Malwadi road,
Hadapsar, Pune
MAHARASHTRA
411028
India
Pune
MAHARASHTRA
411028
India |
| Phone |
9423580963 |
| Fax |
|
| Email |
drnspradhan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
PROF DR MRS NILAKSHI S PRADHAN |
| Designation |
H.O.D. Shalakyatantra |
| Affiliation |
Mams Sumatibhai Shah Ayurved Mahavidhayalay, Hadapsar, Pune |
| Address |
OPD NO. 8, Department of Shalakyatantra, Sane Guruji Arogya
Kendra, Malwadi road,
Hadapsar, Pune
MAHARASHTRA
411028
India
Pune
MAHARASHTRA
411028
India |
| Phone |
9423580963 |
| Fax |
|
| Email |
drnspradhan@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi, Hadapsar,Pune
|
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
OPD NO. 8, Department of Shalakyatantra, Sane Guruji Arogya
Kendra, Malwadi road,
Hadapsar, Pune
MAHARASHTRA
411028
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Hemant Vishwakarma |
M.A.MS Sumatibhai Shah Ayurved Mahavidyalaya |
OPD NO. 8, Department of Shalakyatantra, Sane Guruji Arogya
Kendra, Malwadi road,
Hadapsar, Pune
MAHARASHTRA
411028
India
Pune
MAHARASHTRA |
9920484854
pearl.vishwakarma1994@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:R51||Headache. Ayurveda Condition: suryavarta, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bhringraja swarasadi siddha taila, Reference: Bhavaprakasha nighantu, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting with the clinical features of Suryavarta like headache increases in
mid-day, pain at Akshi (eye region), Bhru (eyebrow region), Lalata (forehead) and Sankha
Pradesh (temporal region).
2. The age group between 18 years to 60 years.
3. Patients of any gender, economic status, religion, occupation.
4. Patient eligible for Nasya karma. |
|
| ExclusionCriteria |
| Details |
1. Patient having any systemic/ chronic illness like hypertension, diabetes.
2. Pregnant and lactating women
3. Headache due to neurological pathologies like tumor, etc.
4. Patient suffering from Dushta Pratishaya. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Symptoms like pain at Akshi(region of eye),
Bhru( eye brows), Sankha(temporal region) and Lalata Pradesh (forehead) will be decreased, subject will get relief from suryavarta |
Follow up will be taken on 4th, 7th, 14th, 21st day.
Symptoms will be noted of before and after treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in severity, duration of pain. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/02/2022 |
| 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="15" |
|
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
|
Suryavarta is among the Shiroroga mentioned by many Acharyas,
It is presented by the clinical features like pain at Akshi (region of eyes) and Bhru
(eyebrow) which increases with the intensity of sun (mid-day) and gradually subsides
with sunset; sometimes it is relieved with cold measures and sometimes with the hot
measures.
Bhringaraja Swarasadi Siddha Taila Nasya in Suryavarta is
mentioned in Bhavaprakasha Nighantu. In treatment of Shiroroga, Nasya is very
effective. As nose (Nasa) is considered as a gateway to Shira. Hence Nasya of above
mentioned drug will be given to the patients who suffer with symptoms like Suryavarta. |