| CTRI Number |
CTRI/2019/06/019523 [Registered on: 04/06/2019] Trial Registered Prospectively |
| Last Modified On: |
05/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
"Ayurvedic Management Of Rheumatoid Arthritis . |
|
Scientific Title of Study
|
"Randomised Controlled Trial Of Panchasam Churna with Vaitaran Basti In The Management Of Amavata With Special Referance To 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 |
Dr Rajesh S Sahu |
| Designation |
PG Kayachikitsa Scholar |
| Affiliation |
Government Ayurved College and Hospital Nagpur |
| Address |
Government Ayurved College and Hospital , Department of Kayachikitsa , 2nd floor,Sakkardara Square Raje Raghuji Nagar ,Nagpur
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9881124656 |
| Fax |
|
| Email |
drrajeshsahu15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayant Gulhane |
| Designation |
Associate Professor Kayachikitsa department |
| Affiliation |
Government Ayurved College and hospital Nagpur |
| Address |
Government Ayurved College and hospital Nagpur,Department of Kayachikitsa ,2nd floor,
raghuji nagar ,sakkardara square Nagpur 440024
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9822922399 |
| Fax |
|
| Email |
jayant.gulhane.62.6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayant Gulhane |
| Designation |
Associate Professor Kayachikitsa department |
| Affiliation |
Government Ayurved College and hospital Nagpur |
| Address |
Government Ayurved College and hospital Nagpur,Department of Kayachikitsa ,2nd floor,
raghuji nagar ,sakkardara square Nagpur 440024
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9822922399 |
| Fax |
|
| Email |
jayant.gulhane.62.6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self(Rajesh Sahu)Kayachikitsa PG Scholar,Department of Kayachikitsa ,Government Ayurvedic college and Hospital Raghuji nagar Sakkardara square Nagpur 440024 |
|
|
Primary Sponsor
|
| Name |
Government Ayurved College and Hospital Nagpur |
| Address |
Government Ayurved College and Hospital Department Of Kayachikitsa Raje Raghuji Nagar Nagpur sakkardara square nagpur 24 |
| Type of Sponsor |
Other [Government Ayurveda College, Nagpur] |
|
|
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 Rajesh Sahu |
Government Ayurved College and Hospital Nagpur |
OPD room no 1,IPD and
Casualty of Government Ayurved College and Hospital Nagpur ,Department of Kayachikitsa ,Raghuji Nagar Sakkardara Square Nagpur 24
Nagpur
MAHARASHTRA |
9881124656
drrajeshsahu15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics comitee Government Ayurved College and Hospital Nagpur |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Devdarvyadi Churna With Vaitaran Basti |
Langhana and Pachana for 3-5 days
oral administration of Devdarvyadi Churna 5 gm for two times per day After meal with lukewarm water.
One Vaitarana Basti for each of consecutive 15 days in morning and
Assessment after completion of treatment
Follow up study after 15 days
Total Duration of Treatment 15 Days |
| Intervention |
Panchasama Churna With Vaitaran Basti |
Langhana and Pachana for 3-5 days
oral administration of Panchasam Churna 5 gm for two times per day After meal with lukewarm water.
One Vaitarana Basti for each of consecutive 15 days in morning
Follow up study after 15 days
Total Duration of Treatment 15 Days |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients having signs and symptoms of Amavata mentioned in Ayurvedic texts.
2) All patients fulfilling a score of 6/10 is needed for classification of a patient as
having definite Rheumatoid Arthritis which is American criteria of Rheumatoid
Arthritis (2010).
3) Patients of either sex aged between 25-70 years.
4) Patient willing and able to participate in the study.
5) Patients who have not participated in any research projects since last 6 months.
6) Patients of rheumatoid arthritis having controlled hypertension and Diabetes
Mellitus may also be included.
7) Patients of Aamvata having Sama Avastha will only be included in study.
|
|
| ExclusionCriteria |
| Details |
1) Patients who are not willing for trial.
2) Patients having gross disability in performing daily normal routine i.e. bed ridden
patients or confined to a wheel chair or have to take help to perform daily routine
activity.
3) Patients having gouty arthritis, syphilitic arthritis, psoriatic arthritis, rheumatic
arthritis, tubercular arthritis, gonococcal arthritis etc.
4) Patients with poorly controlled Hypertension.
5) Patients with poorly controlled Diabetes Mellitus.
6) Patients with the evidence of malignancy.
7) Patients on prolonged medication (>6weeks) with corticosteroids, or any other
drugs that may have an influence on the outcome of the study.
8) Patients who are currently participating in any other clinical trials (since last 6
months).
9) Pregnant or lactating ladies.
10) Patient with chronicity more than >6 years.
11) Patient with contracture and having deformity in the joints.
12) Patients who are contraindicated for Basti Karma.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Panchasam Churna with Vaitarana Basti will be more effective than Devdarvyadi Churna with Vaitarana Basti in the management of Amavat. |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the effect of oral administration of Panchasam Churna with
Vaitarana Basti with that of Devdarvyadi Churna with Vaitarana Basti on clinical features of Amavata and disability index score of Rheumatoid Arthritis
|
18 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/08/2019 |
| Date of Study Completion (India) |
31/08/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL (Not yet) |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Rheumatoid Arthritis (RA) is a chronic inflammatory disease of unknown etiology marked by a systemic, peripheral polyarthritis. Rheumatoid Arthritis (RA) is one of the most common forms of chronic inflammatory arthritis and often results in joint damage and physical disability. RA may result in a variety of extra articular manifestation including fatigue, subcutaneous nodules, lung involvement, pericarditis, peripheral neuropathy, vasculitis and hematological abnormalities. Serum antibodies to cyclic citrullinated peptides (Anti CCP) are routinely used along with Rheumatoid factors as a biomarker of diagnostic and prognostic significance In present era modern medicine prescribes anti-inflammatory Drugs, sometimes steroids are also used. As well as immuno-modulatory agents are also stated. By prescribing these drugs patients have to depend upon drugs for relief. These drugs have hazardous side effects. Apart from these side effects, contracture of joints develops by the time. Thus, patient’s life becomes crippled and treatment is costlier also Vagbhata described complete Samprapti of Vyadhi and Sushruta described it in detail in six stages called as Shatkriyakala. As per these stages Ama along with Tridosha occupies Shleshmasthana (Asthisandhi) and results in painful disease named as “Amavata†All other also described samprapti as above . As per principles of management of Amavata given by different writers Langhana, Svedana, Tikta, Dipana, Katu, Virechana, Snehapana, Vaitarana and Kshar Basti are indicated Chakrapani in Chakradatta has strongly recommended beneficial role of Vaitarana Basti.He stressed to administer Vaitarana and Kshara Basti in Amavata The patients will be diagnosed on the basis of American Criteria of Rheumatoid Arthritis as well as signs and symptoms mentioned in classics. The American Criteria of Diagnosis (2010) Keeping this view minimum 100 patients will be registered and out of these at least 80 patients will be selected randomly by using table of random number using Random number table generator. All these patients will be divided into two groups called as Trial Group and Control Group by lottery method. 80 chits of having same size of same color will be done. 40 chits will be titled as trial Group and 40 chits will be Control Group. Patient will be asked to pick up one of chits and will be included in the group labeled on chit Statistical analysis will be done by considering the quantitative and qualitative data. As per the case, proper tests such as parametric or non-parametric will be evaluated and on the basis of these tests, observations and results will be highlighted accordingly.On the basis of observations and results obtained discussion and conclusion will be described with perspective of Ayurvedic concept. |