| CTRI Number |
CTRI/2018/06/014474 [Registered on: 08/06/2018] Trial Registered Prospectively |
| Last Modified On: |
07/06/2018 |
| 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 Trial to see the effect of some Ayurvedic Formulation in the treatment of Vataja Abhishyanda with reference to Allergic Conjunctivitis |
|
Scientific Title of Study
|
Randomized Clinical Controlled Trial to study the effect of Bilva Panchmooladi Kwath Siddha Ghrita Aschyotana and Olopatadine Eye Drops in Vataja Abhishyanda. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Supriya Suryakant Muddalwar |
| Designation |
MS Scholar |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
OPD no. 09, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Hadapsar, Pune.
Malwadi Road, Hadapsar, Pune.
Pune
MAHARASHTRA
411028
India |
| Phone |
8668844115 |
| Fax |
|
| Email |
smuddalwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilakshi Shekhar Pradhan |
| Designation |
Professor and Head of Department |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
OPD no. 09, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Hadapsar, Pune.
Malwadi Road, Hadapsar, Pune.
Pune
MAHARASHTRA
411028
India |
| Phone |
9423580963 |
| Fax |
|
| Email |
drnspradhan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Supriya Suryakant Muddalwar |
| Designation |
MS Scholar |
| Affiliation |
Sumatibhai Shah Ayurved Mahavidyalaya |
| Address |
OPD no. 09, Department of Shalakyatantra, Sane Guruji Arogya Kendra, Hadapsar, Pune.
Malwadi Road, Hadapsar, Pune.
Pune
MAHARASHTRA
411028
India |
| Phone |
8668844115 |
| Fax |
|
| Email |
smuddalwar@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 |
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 Supriya Suryakant Muddalwar |
Sane Guruji Arogya Kendra, Hadapsar. |
PD no 09, Shalakyatantra department, Sane Guruji Arogya Kendra, Malwadi road, Hadapsar, Pune.
Pune
MAHARASHTRA |
8668844115
smuddalwar@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 |
Vataja Abhishyanda, Allergic Conjunctivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bilva Panchamooladi Kwath Siddha Ghrita Aschyotana |
Bilva,Agnimantha,Shonyak,Patala,Gambhari,Brihati,Eranda,Shigru Siddha Ghrita
Dose-1drop twice a day
Frequency-Twice a day
Administration-Topical
Duration-10 days |
| Comparator Agent |
Olopatadine Eye drops |
Olopatadine is Anti- Histaminic used in the treatment of Allergic Conjunctivitis.
Dose- One drop
Frequency- Twice a day
Administration- Topical instillation
Duration- 10 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from symptoms of Vataja Abhishyanda-Toda,Sangharsha,Shishirashruta,Alpa shopha |
|
| ExclusionCriteria |
| Details |
Pittaja,Kaphaja,Raktaja Abhishyanda
other complications like corneal opacity,corneal ulcer
Systemic diseases like Broncheal Asthama,Allergic Bronchitis,Dermatitis,Allergic Rhinitis,DM,HTN etc will be excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of Bilva Panchmooladi kwath siddha ghrita in vataja abhishyanda. |
The drug will be given for 10 days. The patients will be assessed before and after treatment. Total duration of study will be 18 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To get relief from symptoms of Vataja Abhishyanda |
18 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 1 |
|
Date of First Enrollment (India)
|
20/06/2018 |
| 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="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 open labeled clinical trial to see the effect of Bilva Panchamooladi Kwath Siddha Ghrita Aschyotana instilled twice daily for 10 days in eye/eyes of patients affected with Vataja Abhishyanda. The primary outcome will be effect of Aschyotana in Vataja Abhishyanda.
|