| CTRI Number |
CTRI/2025/05/087424 [Registered on: 22/05/2025] Trial Registered Prospectively |
| Last Modified On: |
22/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Fomentation therapy in management of multiple joint pain |
|
Scientific Title of Study
|
An open labelled randomized comparative clinical study to evaluate the efficacy of sarvanga lavana pottali sweda and sarvanga aavikizhi with nitya virechana in Amavata vis-a-vis Rheumatoid Arthritis |
| 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 Aishwarya P |
| Designation |
PG Scholor |
| Affiliation |
JSS Ayurveda Medical college and hospital |
| Address |
Department of Panchakarma OPD 2 JSS Ayurveda Medical College and Hospital 41 E lalithadripura road, Alanahalli, Mysuru.
Mysore
KARNATAKA
570028
India |
| Phone |
8073050830 |
| Fax |
|
| Email |
aishwaryaaishu70944@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena G Rao |
| Designation |
Professor and HOD |
| Affiliation |
JSS Ayurveda medical college and hospital |
| Address |
JSS Ayurveda Medical College and Hospital 41 E lalithadripura road, Alanahalli, Mysuru.
Mysore
KARNATAKA
570028
India |
| Phone |
9844549152 |
| Fax |
|
| Email |
drveenagrao@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena G Rao |
| Designation |
Professor and HOD |
| Affiliation |
JSS Ayurveda medical college and hospital |
| Address |
JSS Ayurveda Medical College and Hospital 41 E lalithadripura road, Alanahalli, Mysuru.
KARNATAKA
570028
India |
| Phone |
9844549152 |
| Fax |
|
| Email |
drveenagrao@yahoo.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Aishwarya P |
| Address |
JSS Ayurveda Medical College and Hospital, Panchakarma OPD 41 E Lalithadripura road, Alanahalli, Mysuru. |
| 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 |
| Dr Aishwarya P |
JSS Ayurveda Medical college and Hospital, Mysuru |
Department of Panchakarma OPD 2 JSS Ayurveda Medical College and Hospital 41 E lalithadripura road, Alanahalli, Mysuru.
Mysore
KARNATAKA |
8073050830
aishwaryaaishu70944@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:M069||Rheumatoid arthritis, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | sa~gkarasvedaH, संकरस्वेदः | (Procedure Reference: Sarvanga avi kizhi , Procedure details: Sarvanga avi kizhi with dashamoola and amruta churna for 35-40 mins around 7-8 am)
(1) Medicine Name: Dashamula and amruta churna, Reference: Bhavaprakasha nighantu, Route: Topical, Dosage Form: Churna/ Powder, Dose: 350(g), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | sa~gkarasvedaH, संकरस्वेदः | (Procedure Reference: Lavana pottali sweda, Procedure details: Sarvanga lavana pottali sweda with Samudra lavana(crystal salt) for 35-40 mins at around 7-8 am)
(1) Medicine Name: Samudra lavana(crystal salt), Reference: Sushruta samhita,dalhana teeka 46/119, Route: Topical, Dosage Form: Churna/ Powder, Dose: 350(g), Frequency: od, Duration: 7 Days |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects who fulfill diagnostic criteria of Rheumatoid arthritis/Amavata irrespective of gender, religion, occupation and age group between 18-60 years will be included.
2.Subjects with or without on DMARD medications will be included.
3.Subjects fit for Swedana.
4.Subjects fit for Nitya virechana.
5.Both sero positive and sero negative subjects of RA .
|
|
| ExclusionCriteria |
| Details |
1.Subjects with other systemic diseases like uncontrolled Diabetes mellitus, uncontrolled hypertension, which would interfere the present study.
2.Subjects of other connective tissue disorders like SLE, polymyositis, scleroderma etc, other than RA.
3.Subjects who have developed extra-articular complications of RA like pleural effusions, myocarditis, vasculitis etc.
4.Pregnant and lactating women. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain, swelling, stiffness of the joints involved |
0th day and 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in joint tenderness |
8 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
16/06/2025 |
| 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="1"
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
|
Amavata(1) is one of the commonest disorder which is caused due to agni dushti, along with the formation
of ama and vitiation of vatadosha which occupies specific Shleshma stanas i.e. multiple Sandhies which
results in severe Shoola(pain), Shotha(swelling), Stabdatha (stiffness) along with Sarvadaihika lakshanas
of ama. The clinical presentation of Amavata may be closely correlated with that of Rheumatoid arthritis
irrespective of etiological factors.
Rheumatoid Arthritis(2) is a chronic inflammatory disorder of autoimmune origin that may effect many
tissues and organs but principally attacks the joints producing non suppurative proliferative and
inflammatory synovitis. The prevalence of RA is approximately 0.24% to 1% of population. In India, the
prevalence of RA is 0.5% to 0.75%.Peak incidence in third-fourth decades with 3-5 times higher in
females.
The management in Modern science includes the use of NSAID’s (Nonsteroidal anti-inflammatory Drugs),
Glucocorticoids, DMARD’s (Disease Modifying Anti rheumatic Drugs), immunosuppressive therapies.In
spite of advancement in management of Rheumatologic Disorders, the patients with Rheumatoid Arthritis
are treated with drugs which on prolong usage causes hepatotoxicity. Panchakarma therapy is such a
unique module of management which gives beneficial effect.
Ayurveda classics has given a detailed description regarding the management(3) of Amavata which includes
Langhana, Swedana, Deepana with Katu and Tikta Rasa Dravyas, Virechana, Basti, ruksha sweda and
ruksha upanaha.Lavana(4) is having laghu, Deepana, Kaphavatahara and Shulaghna properties. Hence in the present study
Samudra lavana (Crystal salt) is taken as Swedana material for Sarvanga lavana pottali sweda.
Aavi Kizhi is a combination of Bashpa and Pottali sweda by using Dashamoola and Amrutha choorna.
Dashamoola and Amrutha(5) are having Shothahara, Deepana, Pachana, Vatakaphahara, and Jwarahara
properties. Hence in the present study Dashamoola and Amrutha choorna are used as Swedana material
for Sarvanga Aavi Kizhi.
Eranda taila(6) is considered as best for Amavata. It has properties like Snigdha, Tikshna, Sukshma guna,
Madhura vipaka and Ushna virya. It does both Vatakaphahara, Deepana, and Sroto shodhana karma that
helps to tackle Amavata.As the disease has mainly predominance of Ama and Vata dosha, the present study is planned to achieve
Vatahara and Ampachana through two different Sankara swedas i.e.,Sarvanga Lavana pottali sweda to
one group and Sarvanga Aavi kizhi to other group, where both the group receive Nitya Virechana with
Gandharvahasta taila.
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