| CTRI Number |
CTRI/2019/12/022564 [Registered on: 30/12/2019] Trial Registered Prospectively |
| Last Modified On: |
24/12/2019 |
| 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
|
Comparative study of Rasnadi Tail drops nasya and Shadbindu Tail drops nasya in Headache. |
|
Scientific Title of Study
|
Randomised comparative clinical trial to study the efficacy of Rasnadi Tail Nasya and Shadbindu Tail Nasya in Vataja Shirashoola |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinayak Anaji Sirsat |
| Designation |
M.S. scholar Shalakyatantra (Ayurvedic Dhanvantari) |
| Affiliation |
MAMs Sumatibhai Shaha Ayurved College |
| Address |
OPD NO 9, Department of Shalakyatantra,Sane Guruji Arogya Kendra, Malwadi Road, Hadapsar,Pune Maharashtra 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
8668869345 |
| Fax |
|
| Email |
vinusirsat38@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilakshi S Pradhan |
| Designation |
HOD and Professor of Shalakyatantra Department |
| Affiliation |
MAMs Sumatibhai Shaha Ayurved College |
| Address |
OPD no 9, Department of Shalakyatantra,Sane Guruji Arogya Kendra,Malwadi Road,Hadapsar,Pune Maharashtra pin code 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
9423580963 |
| Fax |
|
| Email |
drnspradhan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrVinayak Anaji Sirsat |
| Designation |
M.S. scholar Shalakyatantra (Ayurvedic Dhanvantari) |
| Affiliation |
MAMs Sumatibhai Shaha Ayurved College |
| Address |
OPD no 9,Department of Shalakyatantra ,Sane Gurugi Arogya Kendra,Malwadi Road, Hadapsar,Pune Maharashtra 411028
Pune
MAHARASHTRA
411028
India |
| Phone |
8668869345 |
| Fax |
|
| Email |
vinusirsat38@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakyatantra,Sane Guruji Arogya Kendra Malwadi Hadpasar Pune |
|
|
Primary Sponsor
|
| Name |
Sane Gurugi Arogya Kendra |
| Address |
Sane Gurugi Arogya Kendra, Malwadi, Hadapsar,Pune |
| 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 Vinayak Anaji sirsat |
Sane Guruji Arogya Kendra Malwadi, Hadpasar,Pume 411028 |
OPD NO 8, Department of Shalakyatantra,sane guruji Arogya Kendra Malwadi Hadpasar,Pune-411028
Pune
MAHARASHTRA |
8668869345
vinusirsat38@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R51||Headache, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Rasnadi Taila Nasya |
2-2drops per day in each nostril for 7days |
| Comparator Agent |
Shadbindu Taila Nasya |
2-2 drops per day in each nostril for 7days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient suffering from symptoms of Vataj Shiroshoola irrespective of time period
2) Patient between age group 20 to 60 years
3)Patient of either gender. |
|
| ExclusionCriteria |
| Details |
1)Patients who have known cases of hypertension and dibetes.
2)Secondary headache caused by known cases of meningitis,tumor,encephalitis and refractive errors.
3) Known cases of 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 analouges pain scale)
Bhrama (giddiness)
Shastra arni nibha (Throbbing pain)
Objective criteria (gradation)
1) Severity of headache
2)frequency of headache
3)duration of headache |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Study the concept of vataj shiroshoola and headache in details
Study the Nasya kriya kalpa and its uses,indications,contra indications and the 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)
|
01/01/2020 |
| 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
|
This study is particularly randomised comaparative clinical trial to evaluate the effect of Rasnadi taila nasya given in nasya form(liquid ) 2 drops in each nostril for 7 days with Shadbindu taila nasya given same as Rasnadi taila nasya in Vataj Shiroshoola.The primary outcome will be effect of Rasnadi taila nasya in Vataj Shiroshoola and secondary outcome wiil be to decrease the severity of Vataj Shiroshoola. |