| CTRI Number |
CTRI/2024/09/073546 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
27/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluvate the effect of Ama pachana treatment protocol in modifying disease activity in diagnosed Rheumatoid arthritis subjects |
|
Scientific Title of Study
|
Disease modifying effect of Ama pachana treatment protocol 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 |
Arjun Raj A |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda College, Tripunithura, Ernakulam |
| Address |
Department of Kayachikitsa,
Government Ayurveda College, Tripunithura, Ernakulam
Ernakulam
KERALA
682301
India |
| Phone |
7592954532 |
| Fax |
|
| Email |
drarjunraja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil John Thykkattil |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College, Tripunithura, Ernakulam |
| Address |
Department of Kayachikitsa,
Government Ayurveda College, Tripunithura, Ernakulam
Ernakulam
KERALA
682301
India |
| Phone |
9447500822 |
| Fax |
|
| Email |
drsuniljohn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil John Thykkattil |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College, Tripunithura, Ernakulam |
| Address |
Department of Kayachikitsa,
Government Ayurveda College, Tripunithura, Ernakulam
Ernakulam
KERALA
682301
India |
| Phone |
9447500822 |
| Fax |
|
| Email |
drsuniljohn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College,Tripunithura Ernakulam
kerala PIN- 682301, India |
|
|
Primary Sponsor
|
| Name |
Arjun Raj A |
| Address |
Department of Kayachikitsa
Government Ayurveda college,
Tripunithura, Ernakulam |
| 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 |
| Arjun Raj A |
Department of Kayachikitsa |
Department of Kayachikitsa,
Government Ayurveda College, Tripunithura, Ernakulam
Ernakulam
KERALA |
7592954532
drarjunraja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Committee For Ethics In Research Govt. Ayurveda College ,Tripunithura, Kochi Kerala |
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 | Drug | Classical | | (1) Medicine Name: Punarnavadi guggulu, Reference: Bhaisajya ratnavali- Sotha roga adhikara, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1500(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: -hot water), Additional Information: -Punarnavadi guggulu tab in dose 3 tab (each 500gm) twice after food is given, it includes 6 ingredients namely 1) Punarnava, 2)Devadaru, 3)Haritaki, 4)Guduchi, 5)Gomutra, 6)Shudha guggulu | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: ashtanga hridaya sutrasthana 18th chapter, Procedure details: Rooksha vasti for a period of 7 days ( from 8th day -14th day ) of ama pachana treatment protocol, medicines used are Guduchyadi kashaym -300ml, yasthimadhu choornam- 30gm, saindhavam 5gm. Firstpowdered saindhava is added into the vessel, then yashtimadhu choorna is added followed by the addition of guduchyadi kashaya slowly to get a homogenous mixture, then filtered and given through anal route in lukewarm temperature, time of administration- 10am-11am, schedule - 7 days)
| | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pachanamrutham kashayam, Reference: Sahasrayoga kashayaprakarana, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -it includes 1o ingredients - 1) Amrita, 2)Usira, 3)Vasa, 4)musta, 5)Viswa, 6)Bhunimba, 7)Valaka, 8)Parpata, 9) Dhanyaka 10)Dhanwayasha | | 4 | Intervention Arm | Procedure | - | pariSheka, परिषेक | (Procedure Reference: Ashtanga hridaya sutrasthana 17th chapter, Procedure details: Stream pouring or sprinkling or showering of warm kwatha/ hot medicinal liquid prepared with herbs which destroy or pacify vata or vata-kapha morbidity over the body is called parisheka, here Dhanyamla dhara is used for a period of 7 days ( from 15th - 21st day).)
|
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of Rheumatoid arthritis fulfilling ACR/EULAR classification criteria for RA
Subjects who are fit for vasti
Subjects who are fit for dhanyamladhara
|
|
| ExclusionCriteria |
| Details |
Diagnosed cases of other uncontrolled systemic illness
Subjects with other severe debilitating diseases like cancer
Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Changes in DAS28 score with ESR
2) DAS Based EULAR response criteria |
1) Changes in DAS28 score with ESR- 0th and 21st day of treatment ( before & after treatment)
2) DAS Based EULAR response criteria - 21st day ( after treatment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Ama assessment baseline tool
2) Acute inflammatory marker - CRP |
1) Ama assessment baseline tool- 0th day,8th day, 14 th day and 21st day
2) Acute inflammatory marker - CRP- oth day and 21st day |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
09/09/2024 |
| 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 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
|
Above study postulates an Ama pachana treatment protoco in Rheumatoid arthritis including internal medications like Pachanamrutham kashyam 48ml bd and Punarnavadi guggulu 3bd for a period of 21 days (1st-21stday), Rooksha vasti with Guduchyadi kashaya(300ml), yashtimadhu churna (20gm) and saindhva (5gm) for a period of 7 days ( from 8th - 14th day) and Dhanyamladhara for a period of 7 days ( from 15th- 21st day). The research is found a combination of existing modes of treatment, so that whether they can modify disease activity in Rheumatoid arthritis is assessed. Assessment will be done using DAS28score with ESR and Ama assesment baseline tool on 0th, 8th, 14th, and 21st day. Along with acute inflammatory marker like CRP will be assessed before and after treatment ( Oth - 21 st day) and EULAR response criteria based on DAS 28 will be assessed after the treatment |