| CTRI Number |
CTRI/2021/02/031146 [Registered on: 09/02/2021] Trial Registered Prospectively |
| Last Modified On: |
26/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to see the effect of some Ayurvedic formulation in the form of nasal administration in the treatment of Vataj Shirashoola w.r.t. Headache |
|
Scientific Title of Study
|
Comparative clinical trial to evaluate the efficacy of Baladi Ghritamanda Nasya and Ksheerabala Taila Nasya in the Management of Vataj Shirashoola |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Mahejabeen Munir Jikare |
| Designation |
M.S.Scholar Shalakyatantra |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
OPD No.09, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi road, Hadapsar, Pune
Department of Shalakyatantra, Sane guruji Arogya Kendra, Malwadi road, Hadapsar
Pune
MAHARASHTRA
411028
India |
| Phone |
9623658384 |
| Fax |
|
| Email |
mjikare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilakshi Pradhan |
| Designation |
HOD and Professor of Shalakya tantra Department |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
OPD No.09, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi road, Hadapsar, Pune
Department of Shalakyatantra, Sane guruji Arogya Kendra, Malwadi road, Hadapsar
Pune
MAHARASHTRA
411028
India |
| Phone |
9423580963 |
| Fax |
|
| Email |
drnspradhan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Mahejabeen Munir Jikare |
| Designation |
M. S. Scholar Shalakyatantra (Ayurved) |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
OPD No.09, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi road, Hadapsar, Pune
Department of Shalakyatantra, Sane guruji Arogya Kendra, Malwadi road, Hadapsar
Pune
MAHARASHTRA
411028
India |
| Phone |
9623658384 |
| Fax |
|
| Email |
mjikare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakyatantra, Sane guruji Arogya Kendra, Malwadi road, Hadapsar,Pune |
|
|
Primary Sponsor
|
| Name |
Sane guruji Arogya Kendra |
| Address |
Sane Guruji Arogya Kendra, Malwadi road, 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 |
| Vd Mahejabeen Munir Jikare |
Sane Guruji Arogya Kendra, Malwadi road, Hadapsar, Pune 411028 |
OPD No.09, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Malwadi road, Hadapsar, Pune
Pune
MAHARASHTRA |
9623658384
mjikare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Intitutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R51||Headache, (2) ICD-10 Condition:R51||Headache. Ayurveda Condition: VATAJA-SIROROGAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Baladi Ghritamanda |
It is a formulation of Ayurvedic herbs prepared in the form of ghritamanda for nasal administration(nasya) having Bala and Bilva churna,Goghrita,Ghritamanda ,godugdha(cows milk) which will be administered for nasya 2 drops in each nostril once a day for 7 days. |
| Comparator Agent |
Ksheerabala Taila |
It is formulation of ayurvedic herbs prepared in the form of Taila for nasal administration (nasya) having combination of Balamula,Godugdha (cows milk),Tila Taila which will be administered for nasya 2 drops in each nostril once a day for 7 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)patients suffering from symptoms of Vataj Shiashoola i.e. Shankha Ativedana, Bhru Ativedana, Lalat Ativedana
2)patients of age group 20 to 60 yrs
3)patients of eiter gender will be included in the study
4)patients yogya for Nasyakarma |
|
| ExclusionCriteria |
| Details |
1)patients suffering from Sinusitis,systemic disorder like Hypertension, Diabetes,
2)Secondary Headache caused by Meningitis, Tumour, Encephalitis
3)Pregnancy and Lactation |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
A clinical study to evaluate efficacy of Baladi Ghritamanda Nasya in Vataj Shirashoola w.r.t. Headache.
Subjective Parameters(by using grades and Visual analogue Scale)-Shankha Ativedana,Bhru Ativedana,Lalat Ativedana
Other subjective parameters-Severity of headache, Frequency of headache,Duration of headache |
The drug will be given for 7 days.patient will be assessed before and after treatment.Total duration of study will be 18 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparision between efficacy of Baladi Ghritamanda Nasya and Ksheerabala Taila Nasya in Vataj Shirashoola w.r.t. Headahe. |
Total duration of study will be 18 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/03/2021 |
| 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)?
Response - NO
|
|
Brief Summary
|
This study is open labelled randomised comparative clinical trial to evaluate the effect of Baladi Ghritamanada Nasya 2 drops in each nostril once a day for 7 days in comparison with Ksheerabala Taila Nasya given same as Baladi Ghritamanda Nasya in Vataj Shirashoola w.r.t. Headache. The primary outcome will be effect of Baladi Ghritamanda Nasya and Secondary outcome will be comparison between trial drug and control drug in the management of Vataj Shirashoola w.r.t. Headache. |