| CTRI Number |
CTRI/2015/10/006293 [Registered on: 21/10/2015] Trial Registered Retrospectively |
| Last Modified On: |
27/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of early changes in eye (retina) due to diabetic |
|
Scientific Title of Study
|
Effect of Ayurvedic Treatment protocol in the management of Madhumehajanya Timira w.s.r. to Background Diabetic Retinopathy-A Clinical Study |
| Trial Acronym |
BDR |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepak Kashinath Pawar |
| Designation |
PhD Scholar |
| Affiliation |
Institute for Post Graduate Teaching and Research in Ayurveda |
| Address |
Shalakya Tantra Department Institute for Post Graduate Teaching and Research in Ayurveda Jamnagar IPGT & RA OPPOSITE RELIANCE
SHOPPING MALL PN MARG JAMNAGAR
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
7359906935 |
| Fax |
|
| Email |
drdeep29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Manjusha R |
| Designation |
Professor and HOD of Shalakya Tantra Department |
| Affiliation |
Professor |
| Address |
Shalakya Tantra Department Institute for Post Graduate Teaching and Research in Ayurveda Jamnagar IPGT & RA OPPOSITE RELIANCE
SHOPPING MALL PN MARG JAMNAGAR
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
7600901848 |
| Fax |
|
| Email |
bhatrajma2008@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Deepak Kashinath Pawar |
| Designation |
Ph.D Scholar |
| Affiliation |
Phd Scholar |
| Address |
Shalakya Tantra Department Institute for Post Graduate Teaching and Research in Ayurveda Jamnagar IPGT & RA OPPOSITE RELIANCE
SHOPPING MALL PN MARG JAMNAGAR
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
7359906935 |
| Fax |
|
| Email |
drdeep29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University
Jamnagar – 361008 |
|
|
Primary Sponsor
|
| Name |
Institute for Post Graduate Teaching and Research in Ayurveda Gujarat Ayurved University |
| Address |
Shalakya Tantra Department Institute for Post Graduate Teaching and Research in Ayurveda Jamnagar IPGT & RA OPPOSITE RELIANCE
SHOPPING MALL PN MARG JAMNAGAR
Jamnagar
GUJARAT
361008
India |
| 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 |
| Dr Deepak K Pawar |
IPGT and RA Hospital |
Institute for Post
Graduate Teaching and
Research in Ayurveda
Gujarat Ayurved
University Jamnagar
361008 Jamnagar
Jamnagar
GUJARAT
Jamnagar
GUJARAT |
7359906935
drdeep29@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
Modification(s)
|
| Health Type |
Condition |
| Patients |
Background Diabetic Retinopathy changes, (1) ICD-10 Condition:H36||Retinal disorders in diseases classified elsewhere. Ayurveda Condition: Madhumehajanya Timir, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Anti-hyperglycemic and Anti-DR treatment |
Group B: (Control Group)
Diagnosed cases of DM having DR changes will be included and kept under observation till the whole therapy period. They will be continued with their anti-hyperglycemic and anti-DR treatment, if any. |
| Intervention |
Mukkadi Yoga, Tungadrumadi Taila, Madhumehahar Yoga, Takradhara |
Preparatory phase:
 Deepana Pachana with Trikatu churna (2gm bd) and Luke warm water for five days.
 Kostha Shodhana with Kvatha (40ml) prepared with a compound containing Draksha, Taruni pushpa, Haritaki and Aragvadhamajja (compound Formulation practiced in Maharashtra for Pitta related conditions.) taken in equal quantity will be used for 3-5 days at morning time,
 Followed by Shiroshodhanam by Pippali and Saindhava Avapida Nasya (ref., Sharangadhar Samhita Uttarakhanda) for five days at the same time.
Treatment phase:
1. Marshya Nasya with Tungadrumadi Tail (Ref., Sahasrayogam ) for five days at morning time followed by Pratimarshya nasya with same Tail,
Monthly one sitting, Total 3 sittings.
2. Shirodhara by Siddha-Takra as medium (medicated with Musta and Amalaki) 30 minutes daily for 15 days at the morning time, Monthly one sitting, Total 3 sittings.
3. Vidalaka with Mukkadi yoga (Ref., Sahasrayogam) using Takra as medium at morning time (10 gm powder-5mm thickness of Vidalaka lepa OD for 15 days in a month). Monthly one sitting, Total 3 sittings.
Mukkadi yoga of another ongoing Study may be used for this study as Vidalaka Yoga.
4. Oral Medication (Anubhuta Rasayana yoga )
Dosage Form : capsules of 500 mg each
Dose : 6 caps/3g bd for 3 months.
Anupana : Madhu
Time of administration: Empty stomach, before breakfast in the morning and before dinner in the evening with the advice not to take anything orally for an hour except hot water.
All the above therapies will be continued along with Anti-hyperglycemic treatment as advised by the treating physician. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing for the treatment
Patients of 30-70 yrs having Type-1(Non insulin dependent) with or without visual disturbances, but the detectable ophthalmoscopic features of BDR
Patient of Type-1 (Non insulin dependent) with blood sugar level, FBS- 126 to 220 mg/dl or PPBS-180 to 300 mg/dl with ongoing treatment |
|
| ExclusionCriteria |
| Details |
Patients who are extremely debilitating and those who are not able to withstand treatment procedures.
Patients of Sahaja Prameha (Hereditary).
Patients of Type-1 Diabetes or the patients of Type-2 Diabetes taking Insulin.
High Risk DR or those requiring emergency intervention.
Patients of DR with media opacities like cataract, vitreous degeneration etc. which interfere with ophthalmoscopical findings. Patients having other ocular pathologies like glaucoma, high myopia etc.
Hypertensive Retinopathy and DR associated with pregnancy.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sign and Symptoms of BDR will improve with treatment |
Sign and Symptoms of BDR will improve with treatment within 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| blurring of vision improve |
90 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "102"
Final Enrollment numbers achieved (India)="102" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/09/2015 |
| Date of Study Completion (India) |
27/12/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a randomized parallel clinical study to evaluate the efficacy Ayurvedic Treatment Protocol in patients of BDR. |