| CTRI Number |
CTRI/2021/04/033205 [Registered on: 28/04/2021] Trial Registered Prospectively |
| Last Modified On: |
27/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to evaluate the efficacy of Saindhavadi Rasakriya Anjana in the management of Blepharitis. |
|
Scientific Title of Study
|
A RANDOMIZED OPEN LABEL COMPARATIVE CLINICAL STUDY TO
EVALUATE THE EFFICACY OF SAINDHAVADI RASAKRIYA ANJANA AND TRIPHALA RASAKRIYA ANJANA IN THE MANAGEMENT OF KRIMIGRANTHI WITH SPECIAL REFERENCE TO SEBORRHEIC BLEPHARITIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sivasankari N |
| Designation |
PG scholar |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research |
| Address |
Room no 305, Department of PG Studies in Shalakya Tantra, Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore
Bangalore
KARNATAKA
560082
India |
| Phone |
9535627189 |
| Fax |
|
| Email |
nsivasankari657@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandhya Ganesh |
| Designation |
Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital |
| Address |
Room no 305, Department of PG Studies in Shalakya Tantra, Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore
Bangalore
KARNATAKA
560082
India |
| Phone |
9449349263 |
| Fax |
|
| Email |
drsandyaganeshk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandhya Ganesh |
| Designation |
Professor |
| Affiliation |
Sri Sri College of Ayurvedic Science and Research Hospital |
| Address |
Room no 305, Department of PG Studies in Shalakya Tantra, Sri Sri College of Ayurvedic Science and Research Hospital, Bangalore
KARNATAKA
560082
India |
| Phone |
9449349263 |
| Fax |
|
| Email |
drsandyaganeshk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College of Ayurveda Research Hospital
21st KM Kanakapura Road
Uadayapura P O
Bengaluru 560082 |
|
|
Primary Sponsor
|
| Name |
Dr Sivasankari N |
| Address |
Sri Sri College of Ayurvedic Science and Research Hospital
21st KM Kanakapura Main Road
Udayapura P O
Bengaluru
560082 |
| Type of Sponsor |
Private medical college |
|
|
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 Sivasankari N |
Sri Sri College of Ayurvedic Science and Research Hospital |
21st Km, Kananapura road, Udayapura post, Bangalore-82
Bangalore
KARNATAKA |
9535627189
nsivasankari657@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri institutional Ethical committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H010||Blepharitis. Ayurveda Condition: NETRAROGAH/AKSHIROGAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Saindahavdi Rasakriya Anjana |
1 drop twice a day - 15 days |
| Intervention |
Triphala Rasakriya Anjana |
1 drop twice a day - 15 days |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting with the classical features of Krimigranthi.
2. Patients within the age of 21 to 60 years irrespective of gender, occupation, religion, socio- economic status
and duration of illness. |
|
| ExclusionCriteria |
| Details |
1. Associated with psoriasis and any other skin diseases.
2. Posterior Blepharitis.
3. Ulcerative Blepharitis
4. Parasitic Blepharitis.
5. Mixed Blepharitis.
6. Patients suffering with complications of blepharitis such as conjunctivitis and keratitis. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in blepharitis
Subjective parameters -
1 Kandu
2 Oosha
3 Gharsha
4 Pakshma potavaan
5 Arthi
6 Ashru
|
0th day
16th day
22nd day
29th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in blepharitis
Subjective parameters -
1 Ashru |
0th day
16th day
22nd day
29th day |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2021 |
| 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="0"
Days="0" |
|
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
|
Krimigranthi is one among Sandhi gata Netra Rogas mentioned under Kaphaja Sadhya Vyadhis. It can be correlated to blepharitis in modern system of medicine which is characterized with symptoms like itching, formation of cyst, pain, burning sensation, falling of eyelashes and discharge. Seborrheic blepharitis is one of the most frequently encountered eyelid disorder in all age groups, races and both genders. People getting exposed to the environment which is polluted with dust, smoke and other pollutants affects the eyelid and cause blepharitis. Seborrheic blepharitis is usually associated with seborrhea of scalp (dandruff). It is often a troublesome condition for patients owing to long standing nature of disease. Therefore, this should be treated at the earliest as it affects individual’s social interaction and well being and there is a need to find safe, easily available and economic drug in treating seborrheic blepharitis. The lid margin disease varies among populations and age groups. Study shows that 50% of the population develop the disease with increasing age and contact lens use. In the present clinical study, Saindhavadi Rasakriya Anjana is taken as trial group and Triphala Rasakriya Anjana is taken as control group. Although the condition can be managed, there is currently no cure for this. Therefore, in this present study an effort has been made to evaluate the comparative efficacy of Saindhavadi Rasakriya Anjana and Triphala Rasakriya Anjana in the management of Krimigranthi. |