| CTRI Number |
CTRI/2015/07/006051 [Registered on: 28/07/2015] Trial Registered Retrospectively |
| Last Modified On: |
21/06/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Background Diabetic Retinopathy and its Ayurvedic Management. |
|
Scientific Title of Study
|
Further Clinical study on Pramehajanya Timira (Background Diabetic Retinopathy) and its Ayurvedic Management. |
| Trial Acronym |
BDR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HARIPRIYA H |
| Designation |
M.S. SCHOLAR |
| Affiliation |
INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA |
| Address |
INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA,GUJARAT AYURVEDA UNIVERSITY,JAMNAGAR,GUJARAT
OPD NO.5,DEPARTMENT OF SHALAKYA TANTRA ,INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA,GUJARAT AYURVEDA UNIVERSITY,JASMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
9737433855 |
| Fax |
|
| Email |
drharipriya.nair@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF K S DHIMAN |
| Designation |
PROFESSOR & HOD |
| Affiliation |
INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA |
| Address |
OPD NO 4,DEPARTMENT OF SHALAKYA TANTRA,INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA,GUJARAT AYURVEDA UNIVERSITY,JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| Phone |
9723821965 |
| Fax |
|
| Email |
dr_ks_dhiman@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
PROF MANJUSHA RAJGOPALA |
| Designation |
professor |
| Affiliation |
INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA |
| Address |
OPD NO 4 DEPARTMENT OF SHALAKYA TANTRA ,INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA ,GUJARAT AYURVEDA UNIVERSITY,JAMNAGAR.
Jamnagar
GUJARAT
361008
India |
| Phone |
9428400759 |
| Fax |
|
| Email |
bhatrajma2008@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA,GUJARAT AYURVED UNIVERSITY ,JAMNAGAR. |
|
|
Primary Sponsor
|
| Name |
INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA |
| Address |
OPD No.5 ,DEPARTMENT OF SHALAKYA TANTRA ,INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA,GUJARAT,361008 AYURVEDA UNIVERSITY ,JAMNAGAR. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrHARIPRIYA H |
DEPARTMENT OF SHALAKYA TANTRA,IPGT &RA Hospital,Jamnagar. |
OPD NO.5,DEPARTMENT OF SHALAKYA TANTRA ,INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA
Jamnagar
GUJARAT |
9737433855
drharipriya.nair@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETHICS COMMITTEE,INSTITUTE FOR POST GRADUATE TEACHING AND RESEARCH IN AYURVEDA,GUJARAT AYURVEDA UNIVERSITY,JAMNAGAR .PGT/7/-A/Ethics/2013-14/1767 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
BACKGROUND DIABETIC RETINOPATHY, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Anti-hyperglycemic treatment. |
20 patients already under anti-hyperglycemic treatment by their respective physicians will be taken for observation through out the interventional period. |
| Intervention |
Ayurvedic treatment protocol for BDR starting from Deepana pachana,sadhya snehana ,koshtasodhana,shodhana and samana nasya,sirolepa and oral rasayana drug. |
deepana pachana -Trikatu churna/chitrakadi vati 5g/2 tab bd for 3 days orally.sadya sneha orally with saindhava yuktha goghrita in the evening for a day Koshta sodhana kwatha containing Draksha,hareetaki,taruni pushpa and aragwadha majja(Planned) in equal quantity orally (5 g each with 160 ml water reduced to 40 ml) for 1-3 days depending on koshta in the morning time(kapha pitta kala) Pippali saindhava avapeedanasya (3 g+5 ml water and 4 drops to each nostril) in the morning time for 3 days-transnasally.shamana nasya with drakshadi ghrita(A.H UTTARASTHANA 13/4) 8 drops per nostril for 7 days -2 sitting in 2 months.sirolepa with mukkadi sirolepa yoga(sahasrayoga netraroga prakarana) for 21 days of 2 sitting-transdermal. Oral rasayana drug containing Nisa,Mamalaki,Guduchi,Mustha,Bala,Yashtimadhu,Bhringaraja,Vasa and chitraka (planned yoga with all others 1 part each and purified chitraka 0.5 part )3 g bd in empty stomach for 2 months and honey as adjuvant.(anupana)total thrapy fo 2 months. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Willing for treatment
2.Type 1and 2 DM
3.Visual disturbances may or may not be present.
4.Opthalmoscopical features detectable.
5.Moderate-good glycemic control with on going treatment.
|
|
| ExclusionCriteria |
| Details |
Extremely debilitated pts.
High risk cases
Media opacities-cataract,vitreous degeneration.
HTN retinopathy
Gestational related.
Occular pathologies-Glaucoma,high myopia.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ayurvedic treatment group showed better results than the observation group. |
Ayurvedic treatment group showed better results than the observation group. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| subjective improvement with non-progressing objective symptoms. |
till present study ie.March 2014 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
23/06/2015 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
not yet published. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomised parallel clinical trial to evaluate the role of Ayurvedic management in Background diabetic retinopathy .The treatment group will be provided a holistic approach for Background diabetic retinopathy and control group taking their anti-hyperglycemic treatment will be followed through out the interventional period.selction of patients depending specific criterias.All patients will be evaluated both in modern and Ayurvedic way on the basis of special proforma prepared and scoring pattern. Lab investigations required for the study (Bood and urine RE and Biochemical )will be done in all patients before and after treatment . Clinical assessment will
be done before therapies,at the end of intervention(Total duration 60 days) & also after
completion of follow up period.(1month).The effect of therapy will be statistically analysed using suitable tests.
|