| CTRI Number |
CTRI/2025/02/081115 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
08/02/2025 |
| 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
|
A study to evaluate the efficacy of dwipanchmooladi tailam matra basti in the management of aamvata wsr to rheumatoid arthritis |
|
Scientific Title of Study
|
An open labelled randomized controlled trial to evaluate the efficacy of dwipanchmooladi tailam matra basti , singhnad guggulu, baluka swedana in the management of aamvata w.s.r. to 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 |
Pooja Rani |
| Designation |
M D Panchkarma scholar |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Room no 29 1st floor Institute for Ayurved Studies and Research Shri Krishna AYUSH University Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9996775526 |
| Fax |
|
| Email |
pooja526jangra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Ashish Mehta |
| Designation |
Chairperson PG Department of Panchkarma |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Room no 67 1st floor Institute for Ayurved Studies and Research Shri Krishna AYUSH University Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
8950375285 |
| Fax |
|
| Email |
drashishhmehta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja Rani |
| Designation |
M D Panchkarma scholar |
| Affiliation |
Institute for Ayurved Studies and Research |
| Address |
Room no 29 1st floor Institute for Ayurved Studies and Research Shri Krishna AYUSH University Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9996775526 |
| Fax |
|
| Email |
pooja526jangra@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies and Research Shri Krishna AYUSH University Kurukshetra Haryana 136118 India |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved Studies and Research Shri Krishna AYUSH University |
| Address |
Sector 8 Umri road Kurukshetra 136118 Haryana India |
| Type of Sponsor |
Other [Government Ayurvedic College] |
|
|
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 Pooja Rani |
Institute for Ayurved Studies and Research Shri Krishna AYUSH University |
Room no 29 1st floor Department of Panchkarma
Kurukshetra
HARYANA |
9996775526
pooja526jangra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of University |
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, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charak Samhita, Procedure details: Matra basti 60Ml for 24 days (2 cycles of Basti each 8 days.)Matra Basti will be
given for 8 days then 8 days gap
interval will be kept
then next 8 days
Basti will be given.)
(1) Medicine Name: Dwipanchmooladi Tailam, Reference: Bhavaprakasha Samhita Uttarardha Aamvataadhikar chapter 26 shlok no 114-115, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 24 Days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Singhnad Guggulu, Reference: Bhaishajya Ratnavali Chapter 29 shlok no 190-195, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 24 Days, anupAna/sahapAna: Yes(details: -Sukhoshan jala), Additional Information: -Along with oral drug procedure Baluka Swedana will also be performed once daily for 15-20 minutes on affected joints for 24 days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to sign the consent form
Patients between the age group of 30 to 60 years of either sex
Both fresh and treated
Patients presenting with clinical features of Aamvata mentioned in texts
Assessment of Rheumatoid arthritis by assessment criteria ARA criteria and ACR and
EULAR criteria
Patients with chronicity of disease less than 5 years
Patients fit for Basti Karma
Anti CCP above normal range and or
R A Factor above normal range and or
ESR value should not exceeds 80 mg per dl and or
CRP value above 1 mg per dl |
|
| ExclusionCriteria |
| Details |
Subjects with chronicity of disease more than 5 years
Subjects of either sex age below 30 years and above 60 years
The patients unfit for Basti Karma
Patients having systemic pathologies like Cardiac disease and Hypertension Uncontrolled
Diabetes Endocrine disorders TB of spine Spinal tumours Vertebral fractures Surgical
conditions and Auto Immune disease like Ankylosing spondylitis Already diagnosed
For both groups Rectal prolapse Fever Pregnant and Lactating mothers
Patients with Renal and Hepatic impairment and requiring emergency treatment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The proportion of patients showing improvement in the level of Anti CCP post Basti Karma |
1st - 0 Day
2nd - After the completion of trial
3rd - On follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in R.A Factor level of the patient
Reduction in ESR level of the patient
Reduction in CRP level of the patient
Assesment of Aamvata by clinical features given in Ayurvedic textbooks
Assesment of Rheumatoid Arthritis by Subjective and Objective criteria |
1st - 0 Day
2nd - After the completion of trial
3rd - On follow up |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
03/03/2025 |
| 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
|
Ama and Vata are two words that makeup Aamvata. Ama is thought to be one of the key variables that contributes the onset of illness in the body, due to intae of viruddha aahara, viruddha cheshta, mandagni, avyayaam, snigdha bhukta vyayaam etc. As a result Ama rasa is formed. This Ama is capable to vitiate the doshas, which then circulates in the form of ama and settles in Shleshmasthana where kha-vaigunya is present and cause daurbalya, hridyagaurava, stabdhata etc.Due to their comparable clinical presentations, Aamvata and Rheumatoid Arthritis (R.A) may be connected. Rheumatoid arthritis is a chronic systemic inflammatory disease, R.A clinically presents as polyartheritis involving small and large diarthrodial joints of the extremities usually in asymmetrical pattern.The objectives of treatment for rheumatoid arthritis include reducing pain, inflammation preventing or delaying further joint damage, preserving function at present and relieving weakness and fatigue. Acharya Chakradutta explained the chikitsa sutra of aamvata as Langhan, Swedana, Katu-Tikta, Dipniya Dravya, Virechana, Snehpaan, Anuvasanabasti, KsharBasti. Dwipanchmoola dravya have properties like Tikta, Kashaya, Madhur rasa, Laghu, Ushnaguna, Tridoshhara, Aampachana, Sarvajwarhara. In Ayurveda, Basti treatment is the best amongst panchkarma for Vatvyadhies as it serves manifold purpose. MatraBasti is a type of SnehaBasti, which is unique therapeutic procedure because of its preventive, promotive, rejuvenative and curative properties which helps to suppress Vata. |