| CTRI Number |
CTRI/2020/04/024668 [Registered on: 16/04/2020] Trial Registered Prospectively |
| Last Modified On: |
11/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of pippalyadi anjana And Triphala Rasayana in first stage of cataract |
|
Scientific Title of Study
|
Role Of Pippalyadi Anjana And Triphala Rasayana in Timira(Immature Senile Cataract) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akanksha Singh |
| Designation |
Pg Scholar |
| Affiliation |
Uttrakhand ayurved university Harrawala Dehradun |
| Address |
OPD no-5,Department of Shalakya Tantra,Rishikul Campus uttrakhand ayurved university Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
7895045785 |
| Fax |
|
| Email |
akanksha0729@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gunjan Sharma |
| Designation |
Professor |
| Affiliation |
Uttrakhand ayurved university, Harrawala Dehradun |
| Address |
Opd No-5, Department of Shalakya Tantra,Rishikul campus Uttrakhand ayurved university Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8218428029 |
| Fax |
|
| Email |
gunjan06purity@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gunjan Sharma |
| Designation |
Professor |
| Affiliation |
Uttrakhand ayurved university, Harrawala ,Dehradun |
| Address |
Opd No-5,Department of Shalakya Tantra,Rishikul campus Uttrakhand ayurved university Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8218428029 |
| Fax |
|
| Email |
gunjan06purity@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Rishikul campus UAU Harrawala Dehradun |
| Address |
Opd no 5 Department Of Shalakya Tantra Rishikul Campus Uttarakhand Ayurveda University Haridwar |
| Type of Sponsor |
Government 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 |
| Akanksha Singh |
Rishikul Campus Uttarakhand Ayurved University |
Opd No-5 Department of Shalakya Tantra Rishikul Campus Uttrakhand Ayurveda University Haridwar
Hardwar
UTTARANCHAL |
7895045785
akanksha0729@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: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Pippalyadi Anjana and Triphala Rasayana Vati |
First deepen- pachana(3-7 days),according to the koshth of patient,then topical application of pippalyadi anjana in the form of ointment into the conjunctival fornices from inner canthus to outer canthus in the dose of 3 vidang matra twice in a day with triphala rasayana vati 500 mg BD with normal water for 2 months. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.6/9-6/60 with best corrected visual acuity.
2.patient having sign and symptoms of pratham,dwitiya and tritiya patalagata timira
3.Stage of immature cataract |
|
| ExclusionCriteria |
| Details |
1.patient less than 45 years and more than 70 years.
2.Less than 6/60 with best corrected visual acuity.
3.patient having signs and symptoms of mature and hyper mature cataract.
4.Known case of congenital,developmental,traumatic,complicated and metabolic cataract.
5.patient associated with Hypertension and diabetes mellitus.
6.patient under chemotherapy, steroids and immunosuppressive drugs therapy
7.known case of uvietis,glaucoma and retinopathies. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Delay the progression of senile cataract |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in the associated symptoms of senile cataract |
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
20/04/2020 |
| 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="2"
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
|
Globally, WHO has identified cataract as a first most common cause of preventable blindness among five major blinding eye conditions.Senile cataract is one of the major causes for the age related visual impairment and blindness. In India,there is 50-80% of bilateral blindness is due to cataract. Lack of established conservative treatment for senile cataract evoked the necessity to find an option through treatment modalities in the management. In ayurvedic classics, among various treatment modalities anjana is the foremost procedure which drains out doshas from vartmagat siras,srotas and shringataka marma through mouth, nostrils and eyes.As this is a senile disease swabhav balpravritta vyadhi So, in this aspect orally Rasayana is given which is rejuvenating, nutritious and possess strong antioxidant activity.Considering all these facts, the pippalyadi anjana and triphala rasayana both from yogratnakar has been selected for the present study. |