| CTRI Number |
CTRI/2024/07/069970 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Intake of taila medicated with Madhuyashtyadi drugs followed by evacuation of bowels in Rheumatoid Arthritis |
|
Scientific Title of Study
|
Effect of Madhuyashtyadi taila Snehapana followed by Virechana in 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 Shikha V M |
| Designation |
P G Scholar,Department of Panchakarma |
| Affiliation |
Government Ayurveda Medical College and Hospital |
| Address |
OP No.1,deparertment of panchakarma ,Government Ayurveda Medical College and Hospital,Pulimoodu junction
Thiruvananthapuram
Thiruvananthapuram KERALA 695001 India |
| Phone |
9048544319 |
| Fax |
|
| Email |
shikhavm17@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shikha V M |
| Designation |
P G Scholar,Department of Panchakarma |
| Affiliation |
Government Ayurveda Medical College and Hospital |
| Address |
OP No. 1,department of panchakarma,Government Ayurveda Medical College and Hospital,Pulimoodu junction
Thiruvananthapuram
KERALA 695001 India |
| Phone |
9048544319 |
| Fax |
|
| Email |
shikhavm17@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Manju P S |
| Designation |
Associate Professor,Department of Panchakarma |
| Affiliation |
Government Ayurveda Medical College and Hospital |
| Address |
OP No.1,department of panchakarma,Government Ayurveda Medical College and Hospital,Pulimoodu junction
Thiruvananthapuram
Thiruvananthapuram KERALA 695001 India |
| Phone |
9847317295 |
| Fax |
|
| Email |
manjumahesh1977@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College and Hospital,Pulimoodu junction,Thiruvananthapuram,695001,India |
|
|
Primary Sponsor
|
| Name |
Dr Shikha V M |
| Address |
Government Ayurveda Medical College and Hospital,Pulimoodu junction,Thiruvananthapuram,695001,India |
| 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 Shikha V M |
Government Ayurveda Panchakarma Hospital,Poojappura,Thiruvananthapuram |
In Patient Department of Panchakarma, Government Ayurveda Panchakarma Hospital,Poojappura Thiruvananthapuram KERALA |
9048544319
shikhavm17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee(IEC) Govt Ayurveda College Thiruvananthapuram,Kerala,India |
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: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | acCasnehaH, अचà¥à¤›à¤¸à¥à¤¨à¥‡à¤¹à¤ƒ | (Procedure Reference: charaka chikitsa 29, Procedure details: In the morning after the digestion of previous meal the participant should be seated comfortably and tie the eye with cotton and gauze piece.Madhuyashtyadi taila mezhukupakam heated and melted was administered. after giving taila eye bandage should be removed and give yusha as an anupana.then ask the patient to wash the face and mouth with hot water to remove the upalepatva.Dose of sneha is calculaed based on agni and koshta.According to achrya charaka for shodhana purpose sneha should be taken in madhyama matra (to be digested in 12 hours).first we have to give the sneha in hraseeyasi matra.After observing time taken for digestion on first day the dose for second day is calculated.After attaining the madhyama matra the dose should be continued upto attaing samyak snigdha lakshana.
3 days gap should be given after snehapana.during these days sarvanga abhyanga with pinda tailam and ooshma sweda should do for 15 minutes in morning
) (1) Medicine Name: Madhuyashtyadi Tailam, Reference: Ashtanga Hrdaya Chikitsa Sthana 22, Route: Oral, Dosage Form: Taila, Dose: 25(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Participants satisfying revised ACR/EULAR criteria for Rheumatoid Arthritis
2)Participants with RA factor positive |
|
| ExclusionCriteria |
| Details |
1)Participants with major systemic illness
2)Those who have undergone surgical treatment in affected joints
3)Participants not fit for snehapana and virechana as per ayurvedic classics |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in the disease activity score measured by DAS 28 scale |
0th day,6th day,17th day,23rd day and 47th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in RA factor, ESR,CRP measured by lab investigations |
0th day and 47th day |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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)
|
20/07/2024 |
| 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
|
Rheumatoid arthritis is a chronic inflammatory disorder.It is an autoimmune disorder which occurs when your immune system mistakenly attacks your own body tissues.Rheumatoid arthritis affects the lining of the joints causing a painful swelling that can eventually result in bone erosion and joint deformity. Due to its similar presentations it can be correlate with vatarakta of our classics. The treatment principle of vatarakta includes proper snehana followed by mrdu virechana.Madhuyashtyadi taila mentioned in Ashtanga hrdaya vatarakta chikitsa is an important yoga mentioned in vatarakta chikitsa.The objectives are to determine the effect of Madhuyashtyadi taila snehapana in arohanakrama upto samyak snigdha lakshana followed by virechana in reducing the disease activity score measured by DAS 28 and To determine the effect of shodananga snehapana with madhuyashtyadi taila administered in arohanakrama upto samyaksnigdha lakshana followed by virechana in reducing the haematological parameters like RA factor,CRP,ESR in rheumatoid arthritis.Study design is an experimental study with pre-post test without control group. Participants aged 20-60 years registered in the IPD of government ayurveda panchakarma hospital, poojappura, thiruvananthapuram diagnosed to have rheumatoid arthritis and satisfying inclusion criteria will be selected. The base line data will be collected through interview, laboratory investigations and observations. After collecting base line data, detailed history and examination will be done using clinical case proforma. A total of 20 participants will be selected by consecutive sampling and they were subjected to deepana pachana for 5 days using amrthotharam kashayam 48ml bd before food and shaddharana choorna 6g bd with kashayam and panchakola choornam 12g at 11 am along with takra(anupana). After samyakrookshana lakshana attained snehapana will start with Madhuyashtyadi taila in arohanakrama.The snehapana should be stopped while attained samyak snigdha lakshana. After that abhyanga with pinda thailam and ooshma sweda will be administer for 3 days. Then on the next day virechanam with nimbamrtadi erandatailam should be done. The participants will be assessed on 0thday, before snehapana(6thday) ,after virechana(17thday),on 23rdday and after follow up with regards to changes in subjective parameters . RA factor ,CRP,and ESR will be assessed before treatment (0thday) and after follow up(47th day).Depending upon the distribution of variables, it will be analysed using Wilcoxon’s signed rank test or paired t test or anova test. |