| CTRI Number |
CTRI/2018/02/011819 [Registered on: 09/02/2018] Trial Registered Prospectively |
| Last Modified On: |
08/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical efficacy and safety of Isha Balm |
|
Scientific Title of Study
|
An open label clinical study to evaluate the safety and efficacy of Isha Balm an ayurvedic proprietary topical application for mild to moderate headache and nasal symptoms |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSKeerthiga |
| Designation |
Medical Officer |
| Affiliation |
Isha Arogya Health Centre |
| Address |
Isha Arogya Health Centre
Dept of Ayurveda
Kaya chikatsa(General medicine) division
Room No 5
Natesan Towers
No 48A Vellalar Street Adambakkam
48 A Medavakkam main road, Adambakkam Chennai-600088
Coimbatore
TAMIL NADU
600088
India |
| Phone |
9442590085 |
| Fax |
|
| Email |
keerthiga.black@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSRajesh |
| Designation |
|
| Affiliation |
Isha Arogya Health Centre |
| Address |
Isha Arogya Health Centre
Dept of Siddha
General medicine division
Room No 4
Natesan Towers
No 48A Vellalar Street Adambakkam
48 A Medavakkam main road, Adambakkam Chennai-600088
Coimbatore
TAMIL NADU
600088
India |
| Phone |
9942196781 |
| Fax |
|
| Email |
rajesh.srinivasan@ishaarogya.org |
|
Details of Contact Person
Public Query
|
| Name |
Maa Induba |
| Designation |
Manager |
| Affiliation |
Isha Arogya Health Centre |
| Address |
Isha Arogya Health Centre
Dept of Allopathy
General medicine division
Room No 3
Natesan Towers
No 48A Vellalar Street Adambakkam
48 A Medavakkam main road, Adambakkam Chennai-600088
Coimbatore
TAMIL NADU
600088
India |
| Phone |
9942196781 |
| Fax |
|
| Email |
maa.induba@ishaarogya.org |
|
|
Source of Monetary or Material Support
|
| Isha Arogya Pvt ltd
17 Govidaswami naidu lay out
Coimbatore
|
|
|
Primary Sponsor
|
| Name |
Isha Arogya pvt ltd |
| Address |
Isha Arogya pvt ltd
17 GOVINDASWAMI NAIDU LAY OUT
COIMBATORE
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DrSRajesh |
IshaArogya PVT LTD -Chennai
Natesan Towers,No.48A, Vellalar Street, Adambakkam |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S Keerthiga |
Isha Arogya Health Centre chennai |
Dept of Ayurveda
Kaya chikatsa(General medicine) division
Room No 5
Natesan Towers
No 48A Vellalar Street Adambakkam
Chennai
TAMIL NADU |
9442590085
keerthiga.black@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Isha Arogya Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Headache , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Isha balm |
External application
quantity as required
1-3 days |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1Patients attending the clinic in the age group of 12 years and above and both the sexes included
2 Patients provisionally diagnosed to have viral prodrome, common cold, acute sinusitis, tension headache, migraine headache with the symptom of headache are included the study with their consent.
|
|
| ExclusionCriteria |
| Details |
1 past medical records needing neurological evaluation for headache
2known cases of hypertention, and those getting treatment complications of uncontrolled hypertention
3having ophthalmic complaints
4Patients with serious co-morbid illnesses such as known cardiac vascular disease, cancer induced pain, injuries due to fall or accidents, systemic illness like SLE,etc
• Patients below the age of 12 years and above 60 years.
• Patients who are not willing to give informed written consent.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief from headache |
3 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief from Nasal block |
3 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/02/2018 |
| 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="0"
Months="0"
Days="15" |
|
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 a single arm study among the outpatient attending the clinic. To study the safety and therapeutic efficacy of indigenous herbal formulation of Isha Arogya namely Isha Balm topical application used as a supportive theraphy among patients presenting with headache and nasal symptoms. 30 patients for the period of 15 days.
|