| CTRI Number |
CTRI/2024/04/066135 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
11/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Triphala Ghruta paan and Viddhakarma with antiglaucomatous eye drops in the management of Adhimantha with respect to Glaucoma -A Randomised Controlled Trial. |
|
Scientific Title of Study
|
Effectiveness of Triphala Ghrita Abhyantarpaan and Viddhakarma with antiglaucomatous eye drops in the management of Adhimantha with respect to Glaucoma -A Randomised Controlled Trial. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Padmavati Nikam |
| Designation |
PG Scholar |
| Affiliation |
YMT Ayurvedic Medical College And Hospital |
| Address |
YMT Ayurvedic Medical College And Hospital ,Shalakya Tantra Department ,Ground Floor ,Institutional Area,Sector 4 ,Kharghar,Navi Mumbai,Raigarh Maharashtra 410210
Raigarh
Maharashtra
410210
India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9404240686 |
| Fax |
|
| Email |
padmavati686@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nutan Radaye |
| Designation |
Head of Department |
| Affiliation |
YMT Ayurvedic Medical College And Hospital |
| Address |
YMT Ayurvedic Medical College And Hospital ,Shalakya Tantra Department ,Ground Floor ,Institutional Area,Sector 4 ,Kharghar,Navi Mumbai,Raigarh Maharashtra 410210
Raigarh
Maharashtra
410210
India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9820512695 |
| Fax |
|
| Email |
nutan.radaye.nr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nutan Radaye |
| Designation |
Head of Department |
| Affiliation |
YMT Ayurvedic Medical College And Hospital |
| Address |
YMT Ayurvedic Medical College And Hospital ,Shalakya Tantra Department ,Ground Floor ,Institutional Area,Sector 4 ,Kharghar,Navi Mumbai,Raigarh Maharashtra 410210
Raigarh
Maharashtra
410210
India
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9820512695 |
| Fax |
|
| Email |
nutan.radaye.nr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Padmavati Nikam
Y.M.T.Ayurvedic Medical College and Hospital, PG Institute, Sector -4, Kajrghar, Navi Mumbai - 410210 |
|
|
Primary Sponsor
|
| Name |
Dr Padmavati Nikam |
| Address |
Y.M.T.Ayurvedic Medical College and Hospital, PG Institute, Sector -4, Kajrghar, Navi Mumbai - 410210 |
| Type of Sponsor |
Other [] |
|
|
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 PADMAVATI NIKAM |
YMT Ayurvedic Medical College And Hospital |
OPD and IPD of Shalakya Tantra Department YMT Ayurvedic Hospital ,Institutional Area,Sector 4 ,Kharghar,Navi Mumbai,Raigarh Maharashtra 410210
Raigarh
MAHARASHTRA |
9404240686
padmavati686@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H409||Unspecified glaucoma. Ayurveda Condition: NETRAROGAH/AKSHIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: antiglaucoma eye drops, Reference: a k khurana, Route: Topical, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 1(drops), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: triphala ghrut, Reference: ashtang hrudaya, Route: Oral, Dosage Form: Ghrita, Dose: 40(mg), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: khanda sharkara), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)patients between age group of 40 -70 years.
2)patients having symptoms and signs of adhimantha( glaucoma).
3)intraocular pressure(IOP)rangr from 20.6 to 40 mm hg |
|
| ExclusionCriteria |
| Details |
1) below 40 years and above 70 yrs of age
2) congenital glaucoma
3) hatadhimantha ( absolute glaucoma)
4) retinopathy due to any systemic diseases.
5) any other ocular diseases related to the central nervous system.
6) pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) to assess the effect of triphala ghrita abyantarpaan and viddhakarma in the subjective symptoms of adhimantha.
2) to assess the effect of triphala ghrita anhyantarpaan and viddhakarma on eye pain ,IOP and visual acuity. |
follow up on 0th 7th 14th 21st 28th 35th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) to assess the effect of triphala ghrita abyantarpaan and viddhakarma in the subjective symptoms of adhimantha.
2) to assess the effect of triphala ghrita anhyantarpaan and viddhakarma on eye pain ,IOP and visual acuity. |
follow up on 0th 7th 14th 21st 28th 35th day |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
20/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/05/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [padmavati686@gmail.com].
- For how long will this data be available start date provided 21-09-2023 and end date provided 21-04-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
title - effectiveness of triphala ghrita abyantarpaan and viddhakarma with antiglaucomatous eye drops in the management of adhimantha with respect to glaucoma - a randomised controlled trial.
assessment criteria 1) subjective criteria - netram nirmathyate vedana ardhashiraso vedana shankha danta kapoleshu kapale ruja rupam pashyati dukhhena nayane tivra vedana
2) objective criteria visual acuity assessed by snellens chart IOP assessed by schiotz tonometer CDR AND NRR ratio assessed by opthalmoscopy. |