| CTRI Number |
CTRI/2023/05/052777 [Registered on: 17/05/2023] Trial Registered Prospectively |
| Last Modified On: |
16/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To make and use of Anjana Shalaka Instrument in healthy person in comparison with normal Anjana Procedure |
|
Scientific Title of Study
|
Development and evaluation of the applicability of Anjana Shalaka instrument for Netraprasadana in comparison with conventional Anjana Karma in healthy volunteers. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivkant Sharma |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Ayurved, Parul University |
| Address |
OPD-108, Parul Ayurveda hospital, Shalakya tantra department, Parul institute of Ayurveda, Parul University, At Post-Limda, Tal- Waghodia,
Vadodara, Gujarat
391760
India
Post-Limda, Tal- Waghodia,
Vadodara, Gujarat
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9124927283 |
| Fax |
|
| Email |
shivkants@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Unnati Desai |
| Designation |
Post Graduate Scholar |
| Affiliation |
Parul Institute of Ayurved, Parul University |
| Address |
OPD-108, Parul Ayurveda hospital, Shalakya tantra department, Parul institute of Ayurveda, Parul University, At Post-Limda, Tal- Waghodia,
Vadodara, Gujarat
391760
India
At Post-Limda, Tal- Waghodia,
Vadodara, Gujarat
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9913349479 |
| Fax |
|
| Email |
desaiuv225@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Unnati Desai |
| Designation |
Post Graduate Scholar |
| Affiliation |
Parul Institute of Ayurved, Parul University |
| Address |
OPD-108, Parul Ayurveda hospital, Shalakya tantra department, Parul institute of Ayurveda, Parul University, At Post-Limda, Tal- Waghodia,
Vadodara, Gujarat
391760
India
At Post-Limda, Tal- Waghodia,
Vadodara, Gujarat
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9913349479 |
| Fax |
|
| Email |
desaiuv225@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Ayurveda hospital,Parul University, At P.O-Limda, Tal- Waghodia, VADODARA-391760 |
|
|
Primary Sponsor
|
| Name |
Dean, Parul institute of Ayurveda |
| Address |
Parul Ayurveda hospital, Parul University, At P.O-Limda, Tal-
Waghodia, VADODARA-391760 |
| 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 |
| Unnati Desai |
Parul institute of Ayurveda |
OPD-108,Parul
Ayurveda hospital,
Shalakya tantra
department,Parul
University, At
P.O-Limda, Tal-
Waghodia,
VADODARA-391760
Vadodara
GUJARAT
Vadodara
GUJARAT |
9913349479
desaiuv225@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 |
| Healthy Human Volunteers |
Healthy volunteers who are willing for therapy |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | a~jjanam, अंजनमॠ| (Procedure Reference: Sushruta samhita, Uttartantra , Chapter 18, Procedure details: Volunteer is informed about the procedure and made to lie down comfortably. Application of Anjana Dravya into the conjunctival sac using newly developed Suvarna Anjana Shalaka instrument. Ask volunteer to rotate his eyes after the application of Anjana done keeping the eyes closed. Leave it till cessation of tearing. Prakshalana (Irrigation of eyes) with water. Complete rest for the volunteer with eyes closed for 5 min.)
(1) Medicine Name: Ghrita-Madhu, Reference: Sushruta Samhita, Uttartantra, Chapter 18, Shloka 56, Route: Ocular, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 0.45(g), Frequency: od, Duration: 15 Days | | 2 | Intervention Arm | Procedure | - | a~jjanam, अंजनमॠ| (Procedure Reference: Sushruta samhita, Uttartantra , Chapter 18, Procedure details: Volunteer is informed about the procedure and made to lie down comfortably. Application of Anjana Dravya into the conjunctival sac using Anjana Shalaka (Conventional method). Ask volunteer to rotate his eyes after the application of Anjana done keeping the eyes closed. Leave it till cessation of tearing. Prakshalana (Irrigation of eyes) with water. Complete rest for the volunteer with eyes closed for 5 min.)
(1) Medicine Name: Ghrita-Madhu, Reference: Sushruta Samhita, Uttartantra, Chapter 18, Shloka 56, Route: Ocular, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 0.45(g), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Having good ocular health means that vision is at least 6/6 and the eyes are diseasefree.
Age between 18-35 years, irrespective of gender, caste, religion.
Those who are willing for treatment and ready to give consent as per requirement.
Nirama lakshana of eyes. |
|
| ExclusionCriteria |
| Details |
Patients with ocular manifestations due to serious systemic illness.
Patients with any sign and symptoms mentioned in both classic literature and modern texts like blurred vision, headache, eye strain, watering of eyes, corneal pathologies.
Patient underwent any of the ophthalmic surgeries.
Those who are contraindicated for Anjana. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Development of Anjana Shalaka instrument for Netraprasadana in healthy volunteers. |
6-8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Applicability of newly developed Anjana Shalaka instrument for Netraprasadana in healthy volunteers. |
6-8 months |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/09/2023 |
| 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
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In Ayurveda, Anjana is described as one among the kriyakalpa. We acquire doubtless knowledge with the help of Indriya (sense organ) and out of five indriyas, the prime sense organ is eye. We can prevent our vision by including such therapies in over daily schedule. Netra means eye and application of various medical formulations to eye is called as Anjana. Tremendous importance has been given to Anjana both in healthy person and as well as in ophthalmic patients. The therapy is quite beneficial for the relaxation of eyes and the treatment of various ailments related to eyes. Today, we have developed technologies which are used presently by all age group, they use technology for longer hours, which is a highly vision demanding task. Hence, there is a need to develop a therapy which can help to prevent our eye health. So, we are trying to modify Anjana karma by instrument which can be used by every person in their daily busy schedule and the Anjana Shalaka instrument has such requirement which can fulfil the efficacy of conventional Anjana karma (Anjana procedure).
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