| CTRI Number |
CTRI/2022/02/039904 [Registered on: 01/02/2022] Trial Registered Prospectively |
| Last Modified On: |
21/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial of assessment of Internal use of Triphala ghrita and Blood letting by puncturing with 26 number needle in visualization of black spot in front of both eyes. |
|
Scientific Title of Study
|
A clinical trial of assessment of Triphala Ghrita Snehapana and Asravisravan by Viddhakarma in Dwitiya Patalagata Timir with reference to Vitreous Floaters. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSandhyarani Tukaram Patil |
| Designation |
PG scholar |
| Affiliation |
YMT Ayurvedic medical college and hospital |
| Address |
YMT Ayurvedic Medical college and Hospital, Sector-4, Institutional area,Kharghar,Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
8412994008 |
| Fax |
|
| Email |
sandhyaranipatil15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrNutan Radaye |
| Designation |
Professor |
| Affiliation |
YMT Ayurvedic medical college and hospital |
| Address |
YMT Ayurvedic medical college and hospital Kharghar,Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9820512695 |
| Fax |
|
| Email |
nutan.radaye.nr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrNutan Radaye |
| Designation |
Professor |
| Affiliation |
YMT Ayurvedic medical college and hospital |
| Address |
YMT Ayurvedic medical college and hospital Kharghar,Navi Mumbai
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9820512695 |
| Fax |
|
| Email |
nutan.radaye.nr@gmail.com |
|
|
Source of Monetary or Material Support
|
| At post Ghanand Tal Atpadi Dist Sangli |
| YMT ayurvedic medical college and hospital ,Kharghar,Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Sandhyarani Tukaram Patil |
| Address |
At post Ghanand Tal Atpadi Dist Sangli |
| 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 |
| Sandhyarani Tukaram Patil |
YMT ayurvedic medical college,Kharghar,Navi Mumbai |
OPD and IPD of Shalakyatantra department,Institutiionl area ,Sector-4,Kharghar,Navi Mumbai pin code-410210,Raigarh,Maharashtra
Raigarh
MAHARASHTRA |
8412994008
sandhyaranipatil15@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 |
(1) ICD-10 Condition:PCS||. Ayurveda Condition: Dwitiya Patalagata Timir, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Triphala ghrita abhyanatar pana purvak Viddhakarma | (Procedure Reference: Sushruta Samhita,Sharir sthana,Chapter 8,verse 17, Procedure details: Triphala ghrita abhyantar pana(20 ml) nishakale for 30 days,followed by Viddhakarma with 26 G 1/2 inch needle at Apanaga,Lalaat and Upnasika pradesh.)
(1) Medicine Name: Triphala ghrita, Reference: Ashtanaga hrudayam,Uttara sthana,Chapter 13,Verse 10-11, Route: Oral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: hs, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Visualization of Makshika (fly like), Mashaka, Kesha (hair like), Jala (cobweb), Mandala, Pataka,Marichi, Kundala like structure in front of the eyes in patients with
A)Myopia
B)Hypermetropia
C)Vitreous Opacities
D)Early Posterior Vitreous Detachment
2.Age group between 18- 70 years
|
|
| ExclusionCriteria |
| Details |
1.Diabetic retinopathy
2.Glaucoma
3.Cataract
4.pregnancy and lactation
5.any other ocular disease related to CNS
6.age group below 18 years
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Triphala Ghrita Snehapana and Asravisravan by Viddhakarma is effective in Dwitiya Patalagata Timir with reference to Vitreous Floaters |
Follow up on 0,15th,30th and 45th dat |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not effective |
Same as primary outcome |
|
|
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)
|
08/02/2022 |
| 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="2"
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
|
Title- A clinical trial of assessment of Triphala ghrita Snehapana and Asravisravan by Viddhakarma in Dwitiya Patalagata Timir with reference to Vitreous Floaters.
Assessment criteria- Selected patients will be given Triphala ghrita snehapana for continuous 30 days and Asravisravan by Viddhakarma will be done on 15th and 30th day.Grades of symptoms of dwitiya patalagata timir will be entered on each follow up and compared with initial values.
Subjective Criteria- 1)Visualization of various structures in front of the eyes 2)Subjective gradation chart 3)Floaters questionnaire
Objective Criteria- 1)Visual acuity measured by snellen’s chart for distant vision/LogMAR value 2)Direct fundoscopy 3)A- Scan ultrasound biometry 4)Fundus photography
|