| CTRI Number |
CTRI/2023/12/060496 [Registered on: 04/12/2023] Trial Registered Prospectively |
| Last Modified On: |
09/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Jaloukavacharana(medicinal leech therapy)] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to compare medicinal leech therapy( jaloukavacharana) versus drug gugguluthikthaka taila combined with medicinal leech therapy in lower extremity peripheral arterial disease associated with type 2 diabetes mellitus |
|
Scientific Title of Study
|
Efficacy of gugguluthikthaka taila and jaloukavacharana in lower extremity peripheral arterial disease associated with type 2 diabetes mellitus: A Randomized controlled clinical 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 Deepa Jose |
| Designation |
Assistant Professor |
| Affiliation |
Government Ayurveda College, Tripunithura |
| Address |
Department of Shalyatantra, Government Ayurveda College
Tripunithura
Ernakulam
KERALA
682301
India |
| Phone |
9446864399 |
| Fax |
|
| Email |
jodrdeepa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sreeja Sukesan |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurveda College, Tripunithura |
| Address |
Department of Shalakyatantra, Government Ayurveda College
Tripunithura
Ernakulam
KERALA
682301
India |
| Phone |
7034115701 |
| Fax |
|
| Email |
doctorsreejamd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sreeja Sukesan |
| Designation |
Professor and HOD |
| Affiliation |
Government Ayurveda College, Tripunithura |
| Address |
Department of Shalakyatantra, Government Ayurveda College
Tripunithura
Ernakulam
KERALA
682301
India |
| Phone |
7034115701 |
| Fax |
|
| Email |
doctorsreejamd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College,Tripunithura,Ernakulam |
|
|
Primary Sponsor
|
| Name |
Dr.Deepa Jose |
| Address |
Assistant Professor
Department of Shalyatantra
Government Ayurveda College,Tripunithura,Ernakulam |
| 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 |
| DrDeepa Jose |
Government Ayurveda College Hospital,Tripunithura |
O.P.Room no.4,Department of Shalyatantra, Government Ayurveda College Hospital,
Tripunithura
Pin -682301
Ernakulam
KERALA |
9446864399
jodrdeepa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Committee For Ethics in Research , Govt. Ayurveda College, Tripunithura |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I702||Atherosclerosis of native arteriesof the extremities, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Gugguluthikthaka Taila, Reference: Chikitsa manjari and Ashtanga Hridaya, Route: Oral, Dosage Form: Taila, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: - | | 2 | Intervention Arm | Procedure | - | jalaukAvacaraNam, जलौकावचरणमॠ| (Procedure Reference: Susruta Samhita, Procedure details: intervention 2 -: Bloodletting with medicinal leech.
Numbers of bloodletting : 7 nos.
Interval of bloodletting : 7days.
Site of leech application : Distal ½ of leg & foot in PAD affected lower limb. Days of bloodletting : 1st, 7th, 14th, 21th, 28th, 35th, 42nd days of study period. )
| | 3 | Comparator Arm | Procedure | - | jalaukAvacaraNam, जलौकावचरणमॠ| (Procedure Reference: Susruta samhita, Procedure details: Procedure details: Control intervention -: Bloodletting with medicinal leech.
Numbers of bloodletting : 7 nos.
Interval of bloodletting : 7days.
Site of leech application : Distal ½ of leg & foot in PAD affected lower limb.
Days of bloodletting : 1st, 7th, 14th, 21th, 28th, 35th, 42nd days of study period. ))
|
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. LE-PAD in known T2DM patients diagnosed by clinical examination and colour Doppler study of lower limb arteries.
2. IC due to unilateral or bilateral PAD (Rutherford 1-3) or Rutherford category 0 with atherosclerotic plaques in either femoropopliteal or below popliteal arteries in arterial Doppler study.
3. Age group 40-75 years
4. Atherosclerosis of femoropopliteal and below popliteal arteries in colour Doppler study.
5. Informed written consent
|
|
| ExclusionCriteria |
| Details |
1. Advanced PAD beyond IC (rest pain, ulcer, gangrene, Rutherford 4-6)
2. Prior revascularization in lower extremities in previous 12 months.
3. Neurogenic/venous/orthopedic claudication more dominant than arterial.
2. Acute PAD
3. Buerger’s disease
4. Known cases of Diabetic nephropathy, liver disease, cancer, obesity
5. Contra indication of snehana
6. Cardiac failure
7. Uncontrolled hypertension
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in 6 – minutes walking distance (6MWD) |
Measurement of 6 – minutes walking distance (6MWD) - 0th, 45th and 61st days of study period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Rutherford clinical classification of PAD
2. Colour doppler study of arterial system of affected lower extremities
3. Total Cholesterol, Triglycerides, LDL, HDL, S.Creatinine, Hb,ESR, FBS, PPBS and HbA1C levels |
1.Rutherford clinical classification of PAD - 0th, 45th & 61 days
2. Colour doppler study of arterial system of affected lower extremities - before & after study
3. Total Cholesterol,Triglycerides, LDL, HDL, S.Creatinine, Hb,ESR, FBS, PPBS and HbA1C levels - 0th & 61 days |
|
|
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 3 |
|
Date of First Enrollment (India)
|
04/12/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
This study is a randomized, parallel group single centre trial comparing the efficacy of Gugguluthikthaka taila 15ml bid daily for 60 days combined with Jaloukavacharana ( Medicinal leech therapy) 7times at 7days interval in intervention arm and Jaloukavacharana (Medicinal leech therapy) 7times at 7days interval in control arm in 64 patients with Lower extremity peripheral arterial disease associated with type 2 diabetes mellitus, that will be conducted in single centre, at Government Ayurveda College Hospital,Tripunithura, Ernakulam,Kerala,India. This study is a part of PhD clinical research. The primary outcome measure will be 6- minutes walking distance(6MWD) assessed on 0th, 45th and 61st days of study period. The secondary outcomes will be Rutherford clinical classification of PAD assessed on 0th, 45th and 61st days , Colour doppler study of arterial system of lower extremity will de done before and after study and Total Cholesterol, LDL, HDL, Triglycerides, ESR, Serum Creatinine, Hb, FBS,PPBS and HbA1C on 0th and 61st days.
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