| CTRI Number |
CTRI/2022/09/045698 [Registered on: 20/09/2022] Trial Registered Prospectively |
| Last Modified On: |
19/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
A study of blood letting and panchkarma procedure (oleation and sudation termed as Janu Basti) in the management of osteoarthritis knee pain. |
|
Scientific Title of Study
|
A comparative clinical trial of Raktavasechan (Jalaukavacharana) and Janu Basti in the management of Janu Sandhigata Vata (Osteoarthritis-knee joints) |
| Trial Acronym |
No |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arun Kumar |
| Designation |
PG scholar |
| Affiliation |
Shri Krishna Govt. Ayurvedic College & Hospital |
| Address |
Room No. 67, PG department of Panchkarma, Shri Krishna Govt. Ayurvedic College, umri road sector 8, Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9813454058 |
| Fax |
|
| Email |
arunsheoran313@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arun Kumar |
| Designation |
PG scholar |
| Affiliation |
Shri Krishna Govt. Ayurvedic College & Hospital |
| Address |
Room No. 67, PG department of Panchkarma, Shri Krishna Govt. Ayurvedic College, umri road sector 8, Kurukshetra
HARYANA
136118
India |
| Phone |
9813454058 |
| Fax |
|
| Email |
arunsheoran313@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arun Kumar |
| Designation |
PG scholar |
| Affiliation |
Shri Krishna Govt. Ayurvedic College & Hospital |
| Address |
Room No. 67, PG department of Panchkarma, Shri Krishna Govt. Ayurvedic College, umri road sector 8, Kurukshetra
HARYANA
136118
India |
| Phone |
9813454058 |
| Fax |
|
| Email |
arunsheoran313@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Krishna Govt. Ayurvedic College & Hospital |
|
|
Primary Sponsor
|
| Name |
Shri Krishna Govt Ayurvedic College Hospital |
| Address |
Shri Krishna Govt. Ayurvedic College & Hospital, umri road sector 8, Kurukshetra, 136118 |
| 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 |
| Dr Ashish Mehta |
Shri Krishna Govt. Ayurvedic College & Hospital |
Room No. 67, PG Department of Panchkarma, Shri Krishna Govt. Ayurvedic College, umri road sector 8, Kurukshetra
Kurukshetra
HARYANA |
8950375285
drashishhmehta@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:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | jalaukAvacaraNam, जलौकावचरणमॠ| (Procedure Reference: Sushruta Samhita Sutra Sthana chapter 13, Procedure details: Blood letting from knee joint by using Jaluka (Leech))
4 times in 21 days
0th day - 1st visit for blood letting
7th day - 2nd visit for blood letting
14th day - 3rd visit for blood letting
21th day - 4th visit for blood letting)
| | 2 | Comparator Arm | Procedure | - | jAnu-bastiH, जानà¥-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Keraliya Panchkarma, Procedure details: Heated (Sukhoshan) Tila Tailam is poured over knee joint by making 2 angula height boundary.
Janu Basti will be done once in a day for 21 days)
|
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 40-70 years.
Clinical signs, symptoms, and history of present illness suggestive of primary
osteoarthritis (grade 2and grade 3) |
|
| ExclusionCriteria |
| Details |
→ Patients having age less than 40 year and more than 70 years.
→ Patients having inconclusive diagnosis.
→ Traumatic arthritis, rheumatoid arthritis, psoriatic arthritis, gouty arthritis and
other secondary osteoarthritis.
→ Grade 1, Grade 4, Grade 518 type of primary osteoarthritis will be excluded.
→ Patients having cardiac disease, renal disease, endocrine disorders and
malignancy will be excluded in the study to avoid overlapping of
symptomatology.
→ Coagulopathy disorders will be excluded.
→ Severe Anemia, pregnancy, any kind of noted drug allergy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare Raktavasechan (Jalaukavacharana) and Janu Basti in the management of Janu Sandhigata Vata (Osteoarthritis-knee joints |
1. Jalauka used for Blood Letting 4 times in 21 days
0th day - 1st visit for blood letting
7th day - 2nd visit for blood letting
14th day - 3rd visit for blood letting 21th day - 4th visit for blood letting
2. Janu Basti will be done once in a day for 21 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in osteoarthritic features (pain, stiffness, inflammation and restricted movement) and improvement in life style along with other
subjective parameters. |
Each patient has 21 days study period.
Patient will be assessed weekly to check the improvement in subjective parameters. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/09/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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)?
Response - NO
|
|
Brief Summary
|
SandhigataVata is the common form of SandhigataVyadhi. It is a type of
Vatavyadhi. The word SandhigataVata mainly having two parts: Sandhi Anatomical aspect and Vata- Physiological aspect of body. Acharya Charaka has
described this condition under the chapter of Vatavyadhi and defined that vitiated
Vata when gets its place in Sandhi, then the symptoms like air filled bag
(Vatapurandrittisparsh), Shotha and pain on flexion and extension of joints
(Prasarana Akunchana Pravrittishcha Savedana) occurs.
Acharya Madhavkar also has mentioned the symptoms Hantisandhi, Sandhishula,
Sandhishothaand Atopa². The pathologic underpinning of this diseaseare
attributing to the aberration of Vata Dosha affecting the Asthi (Bone) and Sandhi.
Osteoarthritis is the most common type of arthritis. Its high prevalence especially
in the elderly and its negative impact on physical function make it a leading cause
of disability in the elderly. Osteoarthritis commonly known as wearandtear
arthritis. It is a condition in which the natural cushioning between
jointsi.e.cartilage wears away. When this happens, the bones of the joints rub more
closely to one another with less of the shock-absorbing benefits of cartilage. The
rubbing result in pain, swelling, stiffness, decreased ability to move and sometimes
the formation of bone spurs.Two groups with each group has 30 patients. Group A -To use Jalauka for Blood Letting once in a week for 3 weeks Group B - To use Janu Basti once in a day for 3 weeks |