| CTRI Number |
CTRI/2023/05/053230 [Registered on: 29/05/2023] Trial Registered Prospectively |
| Last Modified On: |
25/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Panchakarma] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the effect of Ayurveda treatment Compared to allopath Treatment in the Management of Amavata (Rheumatoid Arthritis) |
|
Scientific Title of Study
|
A randomized controlled clinical trial on the relative efficacy of ayurveda compared to conventional treatment in the management of amavata (rheumatoid arthritis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Poonam verma |
| Designation |
PhD scholar |
| Affiliation |
All India Institute Of Ayurveda ,New Delhi |
| Address |
Alll India institue of ayurveda gautampuri sarita vihar,new Delhi
South
DELHI
110076
India |
| Phone |
08377885153 |
| Fax |
|
| Email |
dr.poonamverma235@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santoshkumar Bhatted |
| Designation |
Associate professor |
| Affiliation |
All India institute of Ayurveda |
| Address |
Academic block floor 7,room number-703 All india institute of ayurveda gautampuri Sarita Vihar New Delhi
New Delhi
DELHI
110076
India |
| Phone |
9414048459 |
| Fax |
|
| Email |
Santoshbhatted@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santoshkumar Bhatted |
| Designation |
Associate professor |
| Affiliation |
All India institute of Ayurveda |
| Address |
Academic block floor 7,room number-703 All india institute of ayurveda gautampuri Sarita Vihar New Delhi
New Delhi
DELHI
110076
India |
| Phone |
9414048459 |
| Fax |
|
| Email |
Santoshbhatted@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| All India institute of ayurveda gautampuri Sarita Vihar New Delhi 110076 |
|
|
Primary Sponsor
|
| Name |
All India institute of ayurveda |
| Address |
Department of panchakarma ,All india All India Institute Of Ayurveda ,New Delhi institute of ayurveda ,gautampuri Sarita Vihar New Delhi |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Poonam verma |
All India institute of ayurveda |
Academic block Room no-703 Department of Panchakarma
New Delhi
DELHI |
8377885153
dr.poonamverma235@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M059||Rheumatoid arthritis with rheumatoid factor, unspecified. Ayurveda Condition: AMAVATAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | | Conventional treatment Hydroxychloroquine (Low Disease Activity)- 400-600 mg/Day Or Methotrexate (Moderate to Severe Disease Activity) - 10-15mg/Week will be given for 90 days | | 2 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Charak Samhita, Procedure details: Sarvanga Abhyanga with Brihat Saindhavadi Taila and Sarvanga vashpa Swedana with Dashamoola Kwatha will be done for 4 days. On 4th day after sarvang abhyanga and sarvanga bhashpa swedana, virechan medicine will be given )
(1) Medicine Name: Trivrith choorna, Reference: Charak Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 20(g), Frequency: od, Duration: 1 Days(2) Medicine Name: Eranda taila, Reference: Charak Samhita, Route: Oral, Dosage Form: Taila, Dose: 40(ml), Frequency: od, Duration: 1 Days(3) Medicine Name: Kutki Choorna, Reference: Charak Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 10(g), Frequency: od, Duration: 1 Days(4) Medicine Name: Triphala kwath, Reference: Charak Samhita, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 160(ml), Frequency: od, Duration: 1 Days | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: ajmodadi choorna, Reference: sharangdhara, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 4 | Intervention Arm | Procedure | - | sa~gkarasvedaH, संकरसà¥à¤µà¥‡à¤¦à¤ƒ | (Procedure Reference: Charak Samhita, Procedure details: )
| | 5 | Intervention Arm | Procedure | - | AByantarasnehaH , आà¤à¥à¤¯à¤¨à¥à¤¤à¤°Â सà¥à¤¨à¥‡à¤¹à¤ƒ | (Procedure Reference: Charak Samhita, Procedure details: start with 30ml and increase the dose daily until samyak snigdha lakshana or maximum of 7days)
(1) Medicine Name: Murchit Ghrita, Reference: Sharangadhara Samhita, Route: Oral, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Duration: 7 Days | | 6 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Charak Samhita, Procedure details: after samsarjan krama according to shuddhi, anuvasan basti will be done on 1st, 3rd, 5th, 7th, 8th days.Kshara basti will be given 2nd, 4th and 6th day.)
(1) Medicine Name: Brihat Saindhavadi taila, Reference: Charak Samhita, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Duration: 5 Days(2) Medicine Name: Ksharabasti, Reference: Chakradatta, Route: Rectal, Dosage Form: Not Applicable, Dose: 380(ml), Frequency: od, Duration: 3 Days | | 7 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha choorna, Reference: Bhavprakash, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 42 Days, anupAna/sahapAna: Yes(details: Lukewaarm water), Additional Information: -(2) Medicine Name: Amritha ghrita, Reference: Chakradutta, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Sabhakta, Duration: 42 Days, anupAna/sahapAna: No, Additional Information: - |
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Chronicity: < 5 years.
2.Presence of minimum 2 clinical features of Amavata (SandhiShoola,Sandhi Stabdhata)
3.RA (seropositive )
4.The subjects who will fullfill the ACR-EULAR Criteria:2010 (presence of total score ≥ 6 from criteria)
5.Preferably freshly diagnosed cases of Rheumatoid arthritis / old cases after the washout period of one month |
|
| ExclusionCriteria |
| Details |
1. Juvenile R.A.
2.Chronicity: > 5 years.
3.Not willing to participate in the study.
4.Patients with tuberculosis ,Hypertension ,pregnant women.
Patients unfit for Swedana & Basti. |
|
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Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in disease activity DAS -28
• Relief in Cardinal Symptoms such as Pain (Shoola), shotha (swelling), stabdhata (stiffness) ,Range of movements as compared to earlier life style in the patients of Amavata [Rheumatoid artheritis].
|
Reduction in disease activity DAS -28
• Relief in Cardinal Symptoms such as Pain (Shoola), shotha (swelling), stabdhata (stiffness) ,Range of movements as compared to earlier life style in the patients of Amavata [Rheumatoid artheritis].
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Development of a comprehensive Ayurveda score for Amavata (CASA).
• Improvement in HAQ-DI the quality of life . |
120 days |
|
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Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
28/06/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Rheumatoid Arthritis (RA) is a common systemic autoimmune disease that 1% of the world’s population is suffering from it. Epidemiological surveys by WHO –COPCORD(WHO community oriented program for control of rheumatoid disease) shows a prevalence of 0.45% in urban India and 0.7%in rural population, The disease, in addition to reducing the average life expectancy of patients, is associated with significant morbidity. So that 50% of RA patients are not able to continue their jobs after ten years of illness . In Ayurveda commonly used in all the diseases is Samshodhana and Shamana. Samshodhana indicates the Dosha eliminating process, Whereas Shaman brings into equilibrium the aggravated Doshas in the body. Each type of procedure is having its equal importance in their respective way. In modern medical science with extreme advancement in diagnostic approach, It is a challenging disease for the physicians and medical field. Disease-modifying anti-rheumatic drugs (DMARDs) are standard medication for RA patients, methotrexate is one of the commonly used drug to suppress autoimmune response but its side effects is notorious Amavata is one of the devastating diseases that cause permanent disability. The condition is named for its two main pathogenic components, Ama and Vata. these two factors simultaneously take part in theSamprapti making it difficult to treat. According to samprapti wherever this Ama gets localized in the body tissue or joints, it can lead to production of pain, stiffness, swelling, tenderness in related joints.[8] It is not just a problem of the locomotor system; it is also a systemic disease.
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