| CTRI Number |
CTRI/2024/12/077837 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
23/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Kumari Haridra Upanaha in the management of Janu Sandhigata Vata w.s.r Osteoarthritis of Knee |
|
Scientific Title of Study
|
To evaluate the efficacy of Kumariharidra Upanaha over knee joint in the
management of Janu Sandhigata Vata w.s.r to Osteoarthritis of Knee-An Experimental
pilot study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Asra Mehdi |
| Designation |
4th year BAMS student |
| Affiliation |
Sushrutha Ayurvedic Medical College and Hospital |
| Address |
OPD No. 2 Ground floor Sushrutha Ayurvedic Medical College and Hospital Bengaluru
Bangalore
KARNATAKA
560105
India |
| Phone |
9880725586 |
| Fax |
|
| Email |
asramehdi88@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Asra Mehdi |
| Designation |
4th year BAMS student |
| Affiliation |
Sushrutha Ayurvedic Medical College and Hospital |
| Address |
OPD No. 2 Ground floor Sushrutha Ayurvedic Medical College and Hospital Bengaluru
KARNATAKA
560105
India |
| Phone |
9880725586 |
| Fax |
|
| Email |
asramehdi88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja B A |
| Designation |
Associate Professor |
| Affiliation |
Sushrutha Ayurvedic Medical College and Hospital |
| Address |
OPD No. 2, Ground floor, Sushrutha Ayurvedic Medical College & Hospital, Bengaluru
Bangalore
KARNATAKA
560105
India |
| Phone |
9902209309 |
| Fax |
|
| Email |
drpoojaba@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sushrutha Ayurvedic Medical College Pharmacy
Sushrutha Ayurveda Medical College and Hospital
Prashanti Kuteera, Bengaluru 560105 |
|
|
Primary Sponsor
|
| Name |
Sushrutha Ayurvedic Medical College and Hospital Pharmacy |
| Address |
Sushrutha Ayurvedic Medical College & Hospital Prashati Kutiram Jigani Bengaluru 560105 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Pooja B A |
Sushrutha Ayurvedic Medical College & Hospital Prashati Kutiram Jigani Bengaluru |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pooja B A |
Sushrutha Ayurvedic Medical College and Hospital |
No.2 Ground floor Department of Panchakarma Sushrutha Ayurvedic Medical College & Hospital Prashati Kutiram Jigani Bengaluru
Bangalore
KARNATAKA |
9902209309
drpoojaba@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SAMCH & H-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | upanAhasvedaH (sAgniH, उपनाहसà¥à¤µà¥‡à¤¦à¤ƒÂ (सागà¥à¤¨à¤¿à¤ƒ) | (Procedure Reference: bhavaprakasha , Procedure details: A paste is prepared by mixing fresh pulp of the Kumari & Haridra Choorna added with
pinch of Saindhava Lavana & Tila Taila, will be made into lukewarm by indirectly keeping
it over hot water bath.
Thick lukewarm paste will be applied over the knee joint & it is covered with Eranda leaves
further tied with cora cloth. Upanaha will be applied in the morning 8am & will ask the
patient to keep it till evening 6 pm.
Total duration of the treatment 7 days.
)
|
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Janusandhigata Vata/ Osteoarthritis of knee symptoms.
Female patients above 50 year of age post menopause
Male patients above 60 year of age
|
|
| ExclusionCriteria |
| Details |
Subjects suffering from diseases like Amavata (Rheumatoid arthritis), Vatarakta
(Gouty arthritis) or any other systemic disorders.
Secondary Osteoarthritis of Knee.
Subjects who are under Intra-Articular injection of Corticosteroid. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Kumariharidra Upanaha on knee joint is cost effective and easy administrating therapeutic
protocol. .An alternate to knee support and can prevent the further damage over the knee joint
so which indirectly helps to enhance the quality of life. |
Base line and after a week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the quality of life |
1 month |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
15/01/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
SPARK/2024/3403/63
TITLE : To evaluate the efficacy of Kumariharidra Upanaha over knee joint in the
management of Janu Sandhigata Vata w.s.r to Osteoarthritis of Knee-An Experimental
pilot study.
INTRODUCTION:
Sandhigata Vata explained under the heading of Vatavyadhi by Acharya Charaka which
afflicts mainly on Janu Sandhi, in an elderly people presenting with Shoola , Shotha in Janu
Sandhi with Prasarana Aakuncha Vedana (painful,restricted movements)¹
Degenerative and inflammatory pathology in the knee joint is considered as Osteoarthritis
of the knee, commonly presenting with pain, swelling, crepitations and restricted movements.
Life style, overweight, sports or other injury, deficiency are some of the causative factor.
There is a steady rise in prevalence from age 30 such that by 65, 80% of people have
radiographic evidence of OA, though only 25-30% are symptomatic. Due to the increased
prevalence of this disorder and the disabilities produced, it has become a major problem and
burden over the society, indirectly reducing the working potential which results into
dependency.
Available treatment options in modern medicine include use of NSAID’s, calcium
supplementation and ultimately joint replacement.âµ
In Ayurveda, the Chikitsa sutra of Janu Sandhigata Vata includes Svedana and Snehana².
According to Bhavaprakasha, among many formulations mentioned for Upanaha
,Kumari(Aloe vera) and Haridra(Curcuma longa) are specified as both the drugs are having
Shothahara³ and Shoolaharaⴠproperty.
Looking into the limitations in the treatment principles of modern medicine, an attempt is made
here to see the efficacy of Kumariharidra Upanaha on knee joint as it is cost effective and
easily available with easy administration.
Objective: To evaluate the effect of Kumariharidra Upanaha over knee in the management
of Janu Sandhigata Vata.
Materials and methods:-
Source of data:
10 patients of Janu Sandhigata Vata fulfilling the inclusion criteria will be randomly selected
irrespective of age, sex, religion, etc from the OPD and IPD of Sushrutha Ayurvedic Medical
college and Hospital, Bengaluru.
SPARK/2024/3403/63
Drug source:
Fresh Kumari will be procured from the botanical garden of Sushrutha Ayurvedic Medical
college and Hospital, Bengaluru .
Haridra Choorna, Saindhava Lavana and Tila Taila will be procured from the Sushrutha
Ayurveda Central pharmacy.
Diagnostic criteria
1.Pain and Swelling in Knee joint.
2.Crepitations in the knee joint
3.Restricted range of movements of the knee joint
Inclusion criteria
â— Patients with Janusandhigata Vata/ Osteoarthritis of knee symptoms.
â— Female patients above 50 year of age,post menopause
â— Male patients above 60 year of age
Exclusion criteria
â— Subjects suffering from diseases like Amavata (Rheumatoid arthritis), Vatarakta
(Gouty arthritis) or any other systemic disorders.
â— Secondary Osteoarthritis of Knee.
â— Subjects who are under Intra-Articular injection of Corticosteroid.
Intervention
A paste is prepared by mixing fresh pulp of the Kumari and Haridra Choorna added with
pinch of Saindhava Lavana and Tila Taila, will be made into lukewarm by indirectly keeping
it over hot water bath.
Thick lukewarm paste will be applied over the knee joint and it is covered with Eranda leaves
further tied with cora cloth. Upanaha will be applied in the morning 8am and will ask the
patient to keep it till evening 6 pm.
Total duration of the treatment 7 days.
Assessment criteria :
The following criteria will be assessed before (0th day) and after the treatment (08th Day).
WOMAC OA index
SPARK/2024/3403/63
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Name _____________________________ Date of Birth ______________
Today’sDate______________ Height ______ ft. ______ in. Weight________lbs.
Instructions: Please rate the activities in each category according to the following scale of
difficulty: 0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely
Circle one number for each activity
Pain 1. Walking 0 1 2 3 4
2. Stair Climbing 0 1 2 3 4
3. Nocturnal 0 1 2 3 4
4. Rest 0 1 2 3 4
5. Weight bearing 0 1 2 3 4
Stiffness 1. Morning stiffness 0 1 2 3 4
2. Stiffness occurring later in the day 0 1 2 3 4
Physical Function 1. Descending stairs 0 1 2 3 4
2. Ascending stairs 0 1 2 3 4
3. Rising from sitting 0 1 2 3 4
4. Standing 0 1 2 3 4
5. Bending to floor 0 1 2 3 4
6. Walking on flat surface 0 1 2 3 4
7. Getting in / out of car 0 1 2 3 4
8. Going shopping 0 1 2 3 4
9. Putting on socks 0 1 2 3 4
10. Lying in bed 0 1 2 3 4
11. Taking off socks 0 1 2 3 4
12. Rising from bed 0 1 2 3 4
13. Getting in/out of bath 0 1 2 3 4
14. Sitting 0 1 2 3 4
15. Getting on/off toilet 0 1 2 3 4
16. Heavy domestic duties 0 1 2 3 4
17. Light domestic duties 0 1 2 3 4
Total Score: ______ / 96 = _______%
The final score is expressed in percentage and calculated by dividing an individual’s score by
total score and multiplying that by 100
SPARK/2024/3403/63
Implications:
Kumariharidra Upanaha on knee joint is cost effective and easy administrating therapeutic
protocol. .An alternate to knee support and can prevent the further damage over the knee joint
so which indirectly helps to enhance the quality of life.
References
1.Agnivesha,Charaka samhita,Ayurveda deepika commentary by chakrapani,chikitsa
sthana,chapter 28,verse 37,chaukambha orientalia,Varanasi,reprint edition ,2019 ,pg no.618.
2.Sushruta,Sushruta samhita,Nibandha sangraha commentary by dalhana,chikitsa
sthana,chapter 4,verse 8,chaukambha orientalia,Varanasi,reprint edition ,2019 ,pg no.420.
3.Bhavamishra,Bhavaprakasha nigantu,Commentary by Dr.K.C.Chunekar,Edited by
Dr.G.S.Pandey,Haritakyaadi varga,verse 196-197,chaukambha bharati
academy,Varanasi,reprint edition,2006,pg no.114.
4.Bhavamishra,Bhavaprakasha nigantu,Commentary by Dr.K.C.Chunekar,Edited by
Dr.G.S.Pandey,Guduchyaadi varga,verse 229-230,chaukambha bharati
academy,Varanasi,reprint edition,2006,pg no.419.
5.Harrison’s et.al,Harrison’s Principles of Internal Medicine,A Blackiston
publication,6
ð‘¡â„Ž
edition,pg no.1949. |