| CTRI Number |
CTRI/2024/08/072551 [Registered on: 16/08/2024] Trial Registered Prospectively |
| Last Modified On: |
14/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to know the effect of Siddha basti and Siddha basti with valuka sweda in Amavata(Rheumatoid arthritis) |
|
Scientific Title of Study
|
An Open Label Double Arm Comparative Clinical Study On The Effect of Siddha Basti and Siddha Basti with Valuka Sweda in Amavata(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 Pranathi G Kashyap |
| Designation |
2nd Year PG Scholar |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital |
| Address |
Department of Panchakarma
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital OPD 15 and OPD 26 Anchepalya Bengaluru Karnataka
Bangalore KARNATAKA 560074 India |
| Phone |
8147329725 |
| Fax |
|
| Email |
pranathi.kashyap59@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Basavaraj G Saraganachari |
| Designation |
Professor and HOD |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital |
| Address |
Department of Panchakarma
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital OPD 15 Anchepalya Bengaluru Karnataka
Bangalore KARNATAKA 560074 India |
| Phone |
9448008022 |
| Fax |
|
| Email |
drbasugs@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Basavaraj G Saraganachari |
| Designation |
Professor and HOD |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital |
| Address |
Department of Panchakarma
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital OPD 15 Anchepalya Bengaluru Karnataka
Bangalore KARNATAKA 560074 India |
| Phone |
9448008022 |
| Fax |
|
| Email |
drbasugs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital Bengaluru |
|
|
Primary Sponsor
|
| Name |
Dr Pranathi G Kashyap |
| Address |
Department of Panchakarma Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital OPD 15 and OPD 26 Bengaluru Karnataka 560074 |
| 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 Pranathi G Kashyap |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital |
OPD 15 and OPD 26
Department of Panchakarma Bangalore KARNATAKA Bangalore KARNATAKA |
8147329725
pranathi.kashyap59@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M059||Rheumatoid arthritis with rheumatoid factor, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•रà¥à¤®/वसà¥à¤¤à¤¿à¤•रà¥à¤® | (Procedure Reference: Vangasena samhita basti karma adhikara, Procedure details: Siddha basti in the form of yoga basti for 8 days) (1) Medicine Name: Siddha basti, Reference: Vangasena samhita basti karma adhikara, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 552(ml), Frequency: od, Duration: 8 Days | | 2 | Comparator Arm | Procedure | - | piNDasvedaH, पिणà¥à¤¡à¤¸à¥à¤µà¥‡à¤¦à¤ƒ | (Procedure Reference: Charaka samhitha swedhadyaya, Procedure details: To assess the added effect, Sarvanga valuka sweda is done along with Siddha basti for 8 days in comparator group)
|
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Amavata with features of Rheumatoid arthritis as specified in 2010 ACR-EULAR classification criteria.
2.Irrespective of serological negativity and positivity are included for the study.
3.Patients fit for Basti karma.
4.Patient of either gender with the age group 30 to 60 years.
5.Recent onset and less than or equal to 5 years of chronicity.
6.Considering disease activity and functional impairment STAGE-1, STAGE-2
7.Patients voluntarily willing to participate in the study and ready to sign consent form.
|
|
| ExclusionCriteria |
| Details |
1.Patients with known case of uncontrolled hypertension and diabetes mellitus.
2.Patients with cardiac manifestations.
3.Patients diagnosed with other degenerative and inflammatory joint diseases, history of knee implants and total knee replacement surgeries.
4.Patients with the signs and symptoms of Pravruddha amavata21 with joint deformities STAGE-3, STAGE-4.
5.Active tuberculosis, Ulcerative colitis, Irritable bowel syndrome or other sever systemic and endocrine disorders.
6.Patients of Ano-Rectal disorders.
7.Pregnancy and lactating women.
8.Patients with cerebrovascular accident.
9.Patients who are receiving chemotherapy and radiotherapy.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Significant improvement in Sandhi shola (joint pain) measured using VAS(Visual analog scale)
• Significant improvement in Sandhi sthabdhata(morning stiffness) using Gradings
• Significant improvement in Sandhi shotha(joint swelling) using gradings
• Significant improvement in Tenderness using gradings
|
0th day(before treatment),9th day(after treatment) and 24th day(after treatment)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Significant improvement in DAS 28Score
• Improved Quality of life related to joints.
|
0th day(before treatment), 9th day(after treatment) and 24th day(after treatment) |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/09/2024 |
| 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 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
|
In the present era, due to a sedentary lifestyle, consumption of incompatible food, hectic work schedules, improper physical activities, stress and many such reasons, individuals are prone to develop distressing clinical conditions which are mainly caused due to impaired digestion and metabolism. Amavata is one such crippling disease claiming maximum loss of human power where there is formation and deposition of Ama at all levels of body physiology. The symptoms of Amavata have strong parlance with Rheumatoid arthritis observed as an autoimmune and a systemic inflammatory disease that is characterized by a progressive and disabling course with a prevalence rate of 0.24% which has drastically increased up to 0.5% -1% over a decade, with a woman to man ratio of 3:1. It is 4-5 times higher in women under 50 years, but after 60 years the ratio becomes approximately 2:1 globally. Family studies indicate a genetic predisposition and patients with first-degree relatives possessing the auto antibody are found to have 2 - 1 times greater risk of developing severe arthritis than the general population. In contemporary science, NSAIDs, DMARD, immunosuppressants and Steroids are widely used which do only symptomatic relief with no cure but have high chances of developing co-morbidities. In Ayurveda, Siddha basti mentioned in Vangasena samhita and Valuka sweda mentioned in Yogaratnakara are mainly indicated for Amavata(Rheumatoid arthritis) as both the treatment modalities do vata kapha prashamana which is the main cause for the disease. Basti karma has been selected as it is the prime treatment for vata dosha not only in curative and preventive aspects of diseases but also in promotive aspects hence considered as chikitsardha by our Acharyas. Valuka sweda does kapha, shotha and shoolahara inturn subsides ama. Hence this study is undertaken to evaluate the effect of Siddha basti and the additive effect of Sarvanga Valuka sweda along with Siddha basti in Amavata (Rheumatoid arthritis). |