| CTRI Number |
CTRI/2019/09/021431 [Registered on: 27/09/2019] Trial Registered Prospectively |
| Last Modified On: |
25/09/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
An Ayurvedic management in pterygium. |
|
Scientific Title of Study
|
A COMPARATIVE STUDY ON EFFECT OF SHASTRAVARTI ANJANA AND NAYANASUKHAVARTI ANJANA IN THE MANAGEMENT OF ARMA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sudhakar |
| Designation |
PG scholar |
| Affiliation |
Government Ayurveda Medical College, Bangalore. |
| Address |
Department of PG studies in Shalakya tantra, Shalakya tantra OPD, room no. 9, Government Ayurveda Medical College, Bangalore
Bangalore
KARNATAKA
560009
India |
| Phone |
9448567798 |
| Fax |
|
| Email |
drsudhakarayush@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Syed Munawar Pasha |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda Medical College, Bangalore. |
| Address |
Department of PG studies in Shalakya tantra, Shalakya tantra OPD, room no. 9, Government Ayurveda Medical College, Bangalore
Bangalore
KARNATAKA
560009
India |
| Phone |
9886593932 |
| Fax |
|
| Email |
smpasha78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudhakar |
| Designation |
PG scholar |
| Affiliation |
Government Ayurveda Medical College, Bangalore. |
| Address |
Department of PG studies in Shalakya tantra, Shalakya tantra OPD, room no. 9, Government Ayurveda Medical College, Bangalore
KARNATAKA
560009
India |
| Phone |
9448567798 |
| Fax |
|
| Email |
drsudhakarayush@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Sudhakar |
| Sri Jayachamarajendra Institute of Indian Medicine Hospital, Government Ayurveda Medical College campus, Bangalore |
|
|
Primary Sponsor
|
| Name |
Dr Sudhakar |
| Address |
Department of PG studies in Shalakya tantra, Shalakya tantra OPD, room no. 9, Government Ayurveda Medical college, Bangalore-560009 |
| Type of Sponsor |
Other [Self] |
|
|
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 Sudhakar |
Sri Jayachamarajendra Institute of Indian Medicine Hospital |
Shalakya tantra OPD, room no. 9, Government Ayurveda Medical College campus, Dhanvantari road, Bangalore-560009
Bangalore
KARNATAKA |
9448567798
drsudhakarayush@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee, Government Ayurveda Medical College, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H110||Pterygium of eye, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nayanasukhavarthi anjana |
Nayanasukhavarthi anjana is applied once in a day in morning, daily for 2 months. |
| Intervention |
Shastravarti anjana |
Shastravarti anjana is applied once in a day in morning, daily for 2 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinical features as per classics
2. Pterygium which limited to limbus
|
|
| ExclusionCriteria |
| Details |
1. Those who suffering from conjunctival Xerosis,Vit-A deficiency and Xeropthalamia.
2. Acute Infections of eye.
3. Pseudopterygium
4. Those contraindicated for Anjana therapy.
5. Subject suffering from any chronic Debilitating disorders.
|
|
|
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 |
| Pictorial presentation |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual acuity |
2 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
28/09/2019 |
| 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="6"
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)?
|
|
Brief Summary
|
6 NEED FOR THE STUDY:
Arma is the shuklagataroga described in classical texts of Ayurveda by AcharyaSushruta and Vagbhata. Based on site of manifestation, clinical presentation and surgical method of management Arma can be compared with pterygium which is common disorder of ocular surface. The epidemiological studies have shown that the prevalence rates of Pterygium range between 0.3% and 37.46% globally.Pterygium prevalence in rural central India is about 13%, among the adult Indian aged above 30 years. Older age, male gender, lower educational level and more time spent outdoors with vigorous were associated factors. Pterygium is a fibro vascular degeneration of conjunctiva, commonly encroaching on to the cornea. It is usually triangular or wing shaped. It not only affects beautiful outlook of the patient, but also leads refractive astigmatism and is a potentially blinding disease in the advanced stage due to invasion of the visual axis, which can have significant impact on vision. Basically treatment of pterygium in modern medicine is surgical excision, 90% pterygium surgeries are successful, and complications though rare are more serious. Even though surgical treatments are available, the hardship caused due to the surgery and the cost associated with it is high and recurrence rate is 30-50%. Considering these lacunas in modern science has stressed upon the need for the study for effective measure which can cure the condition and prevent recurrence and hence the present study has been taken up.
HYPOTHESIS:
NULL HYPOTHESIS- H0: Shastravartianjan has no effect in arma management. ALTERNATE HYPOTHESIS- *H1: There will be significant effect of shastravartianjana in the management of arma.
*H2: There will be significant effect of Nayanasukhavartianjana in the management of arma.
*H3: Both Shastravartianjan and Nayansukhavartianjana have significant effect in the management of arma. |