| CTRI Number |
CTRI/2024/10/075601 [Registered on: 22/10/2024] Trial Registered Prospectively |
| Last Modified On: |
21/10/2024 |
| 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
|
To evaluate the efficacy of PIPPALIYUKT DASHMOOL KWATH in the management of Amavata in comparative with RASONADI KWATH. |
|
Scientific Title of Study
|
A Randomized controlled clinical trial to study the efficacy of PIPPALIYUKT DASHMOOL KWATH with RASONADI KWATH in the management of Amavata. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd. Bhagyashri Pralhad Patil |
| Designation |
MD Scholar (Kayachikitsa) |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Aayurved Mahavidyala Department of Kayachikitsa, 1st floor 583/2 Rasta Peth, Pune-411011, Maharashtra, India
Pune
MAHARASHTRA
411011
India |
| Phone |
8956337215 |
| Fax |
|
| Email |
bhagyashrip898@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sangeeta P. Sawant |
| Designation |
Ass. Professor Kayachikitsa Department |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Aayurved Mahavidyala Department of Kayachikitsa, 1st floor 583/2 Rasta Peth, Pune-411011, Maharashtra, India
Pune
MAHARASHTRA
411011
India |
| Phone |
9130774107 |
| Fax |
|
| Email |
sangeetap14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Bhagyashri Pralhad Patil |
| Designation |
MD Scholar (Kayachikitsa) |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Aayurved Mahavidyala Department of Kayachikitsa, 1st floor 583/2 Rasta Peth, Pune-411011, Maharashtra, India
Pune
MAHARASHTRA
411011
India |
| Phone |
8956337215 |
| Fax |
|
| Email |
bhagyashrip898@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth Tarachand Ramanath Charitable Ayurvedic Hospital 580/2 Rasta peth pune. |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya |
| Address |
Tilak Aayurved Mahavidyala Department of Kayachikitsa 1st floor 583/2 Rasta Peth Pune-411011 |
| Type of Sponsor |
Private medical 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 Bhagyashri Pralhad Patil |
Seth Tarachand Ramnath Ayurvedic Hospital Pune |
Tilak Aayurved Mahavidyala Department of Kayachikitsa, 1st floor 583/2 Rasta Peth, Pune-411011, Maharashtra
Pune
MAHARASHTRA |
8956337215
bhagyashrip898@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional ethical committe, TAMV pune |
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 | Drug | Classical | | (1) Medicine Name: Pippaliyukt Dashmool Kwath, Reference: Harit Samhita Dvitiy Sthan 29/24, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 100(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 6 Months, anupAna/sahapAna: Yes(details: ushna Jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rasonadi Kwath, Reference: Bhaishjyaratnavali Aamvata Prakaran 29/23, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 6 Months, anupAna/sahapAna: Yes(details: -Ushn Jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient who have classical symptoms of Aamvata like Sandhishool, Sandhishotha, Sparshasahatva, Sandhinigrah, Agnimandya, Aruchi, Daha, Alasya, Jwar, Trishna, Gaurav.
2.Patients who are not on any conventional medicine such as Methotrexate, Cloroquine, Glucocorticoids in the last one month prior to period.
3.Patient willing to give informed consent. |
|
| ExclusionCriteria |
| Details |
1. Traumatic Arthritis, Psoriatic Arthritis, Gouty Arthritis, Septic Arthritis, Pots disease.
2.Comorbid conditions such as past history of Cardiac Arrythmia, Acute coronary Syndrome, Diabetes, Hypertension, MI, Stroke, Renal dysfunction in last 3 months.
3.Patient taking participation in any other clinical trial in last 3 months.
4.History of allergic response/hypersensitivity to trial formulation or its ingredients.
5.Patient not willing for clinical trial.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in symptoms like Sandhishool, Sandhistabdhata, Sparshaasahatva, Sandhishoth, Aruchi, Angagaurav, Daha, Agnimandya, Angamarda |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in symptoms like Sandhishool, Sandhistabdhata, Sparshaasahatva, Sandhishoth, Aruchi, Angagaurav, Daha, Agnimandya, Angamarda |
6 Months |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
10/11/2024 |
| 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
|
In this study Pippaliyukta Dashmool Kwath and Rasonadi Kwath will be given to the group A & B respectively.Efficacy will be assessed on the basis of objective criterias for statistical analysis. Gradations will be designed according to symptoms and each symptom will be scoredbefore and after treatment and on every weekly follow up.The effect of treatment result will be assessed in regards to clinical signs and symptoms on the basis of grading and scoring system.The signs and symptoms will be asesed by adapting the suitable scoring system. |