| CTRI Number |
CTRI/2025/02/081295 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Development of an automated Portable Parisheka device and its comparative efficacy with traditional Parisheka using Dashamoola Kashaya in the management of Amavata (Rheumatoid Arthritis) |
|
Scientific Title of Study
|
Development of an automated portable Parisheka device and a comparative study of its efficacy with traditional Parisheka using Dashamoola Kashaya in Amavata (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 ARUN N K |
| Designation |
PhD Scholar |
| Affiliation |
All India Institute of Ayurveda New Delhi |
| Address |
Department of Panchakarma 7th Floor Academic block, All India Institute of Ayurveda Gautampuri Awas Sarita Vihar New Delhi India
South
DELHI
110076
India |
| Phone |
9061180158 |
| Fax |
|
| Email |
arunnarayan.nk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PRASANTH DHARMARAJAN |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Ayurveda New Delhi |
| Address |
Department of Panchakarma 7th Floor Academic block All India Institute of Ayurveda Gautampuri awas Sarita vihar New Delhi
South
DELHI
110076
India |
| Phone |
9895174060 |
| Fax |
|
| Email |
drprasanthd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ARUN N K |
| Designation |
PhD Scholar |
| Affiliation |
All India Institute of Ayurveda New Delhi |
| Address |
Department of Panchakarma 7th Floor Academic block, All India Institute of Ayurveda Gautampuri Awas Sarita Vihar New Delhi India
South
DELHI
110076
India |
| Phone |
9061180158 |
| Fax |
|
| Email |
arunnarayan.nk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Scholar and All India Institute of Ayurveda, Sarita Vihar, South Delhi, 110076 India |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
NH19, Gautampuri Awas, Sarita Vihar, New Delhi, India 110076 |
| Type of Sponsor |
Government medical college |
|
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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 |
| Dr Arun NK |
All India Institute of Ayurveda New Delhi |
OPD Number 6, Ground floor, Hospital block, All India Institute of Ayurveda New Delhi. Sarita vihar 110076
South
DELHI |
9061180158
arunnarayan.nk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Division of Translational Research and Biostatistics |
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:M058||Other rheumatoid arthritis with rheumatoid factor. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | pariSheka, परिषेक | (Procedure Reference: Ashtanga Hridayam, Procedure details: Continues pouring of luke warm dashamoola kashaya through body with the help of developed automated portable parisheka device for the duration of 40 to 45 minutes)
(1) Medicine Name: Dashamoola Kashayam, Reference: Ashtanga Hridayam Sutrasthana, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 4000(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | pariSheka, परिषेक | (Procedure Reference: Ashtanga Hridayam Sutrasthana, Procedure details: Continues pouring of luke warm dashamoola kashaya through body with classical method for the duration of 40 to 45 minutes )
(1) Medicine Name: Dashamoola Kashaya, Reference: Ashtanga Hridayam Suthrasthana, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 4000(ml), Frequency: od, Duration: 7 Days |
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 20 to 60 years, irrespective of gender, presenting with clinical features of Amavata with Paithika characteristics such as Daha and Raga as described in Ayurvedic classics, and having a confirmed diagnosis of Rheumatoid Arthritis fulfilling the EULAR 2010 criteria, will be included. The study will consider RA patients with tenderness and chronicity of less than 5 years or those who are freshly diagnosed. Eligible participants must be suitable for Swedana procedures and should not have taken NSAIDs or short-acting steroids for the past 1–2 weeks. Additionally, patients must be willing to provide informed consent and adhere to the study protocol |
|
| ExclusionCriteria |
| Details |
Exclusion criteria include patients suffering from paralysis affecting motor function, diagnosed cases of neoplasm of the spine, gout, traumatic arthritis, or pyogenic osteomyelitis. Patients with comorbidities such as cardiac disease, pulmonary tuberculosis, uncontrolled diabetes mellitus, inflammatory bowel disease, malignant hypertension, or renal function impairment, as well as pregnant women and lactating mothers, will not be included. Individuals contraindicated for Swedana procedures or those with severe peripheral artery disease or other significant vascular conditions that could be worsened by Parisheka therapy are also excluded |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in pain scores (VAS) and Reduction in inflammatory markers (CRP, ESR) and achievement of Samyak Swedana Lakshana
|
0 days, 8 days or 15 days or 22 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Patient’s and Administrator’s responses, Dermalab parameters during Parisheka using the automated portable device versus the traditional method. |
0 days, 8 days or 15 days or 22 days |
|
|
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)
|
02/12/2025 |
| 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
|
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Brief Summary
|
RESEARCH QUESTION Does the development of an automated portable Parisheka device improve the efficiency in the administration of Dashamoola Kashaya Parisheka procedure and its effectiveness of pain management in Amavata compared to the traditional method of Parisheka?
HYPOTHESIS Automated portable Parisheka device will be more efficient in the administration of Dasamoola Kashaya Parisheka procedure and more effective in the management of pain in Amavata compared to the traditional method of Parisheka Null Hypothesis (Ho): There is no difference in the efficiency of Dashamoola Kashaya Parisheka and its effectiveness in the management of pain in Amavata when done with automated portable Parisheka device compared to the traditional Parisheka procedure. Alternative Hypothesis (H1): The developed automated portable Parisheka device has superior efficiency in the administration of Dashamoola Kashaya Parisheka and is more effective in the management of pain in Amavata compared to the traditional Parisheka procedure. AIM Develop an automated portable Parisheka device and evaluate its efficacy compared to that of traditional Parisheka procedure in Amavata OBJECTIVES: Ø Primary Objective: 1. To develop an automated portable Parisheka device that is capable of administering Parisheka effectively and uniformly. Ø Secondary Objective: 1. To check the Patient’s and Administrator’s responses during Parisheka procedure with automated portable Parisheka device and with current traditional method. 2. To evaluate and compare the efficacy of the automated portable Parisheka device with the traditional Parisheka method in Amavata (Rheumatoid Arthritis) by using Dashamoola Kashaya Parisheka and Pachana medicine. 3. To compare the changes in following parameters of Dermalab instrument before and after Dashamoola Kashaya Parisheka and Pachana medicine. Ø Skin pH Ø Skin sebum Ø Skin hydration Ø Skin color Ø TEWL Video microscopy Ø Skin Elasticity Ø Temperature 4. To compare the changes in the following parameters before and after Dashamoola Kashaya Parisheka with Pachana medicine and compare it within 2groups. A. Inflammatory markers ie., CRP, ESR B. Samyak Swedan lakshana assessment. C. Pain assessment with Visual Analoge Score PLAN OF STUDY The study will be carried out in the following phases 1. Survey study 2. Device Designing and Development 3. Validation 4. Clinical study
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