| CTRI Number |
CTRI/2024/12/078397 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Rasnadinavak
Kwath In The Management Of Amvata |
|
Scientific Title of Study
|
Randomised controlled clinical Study to assess the efficacy of Rasnadinavak Kwath in the management of Amvata |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rucha Vijay Adsul |
| Designation |
PG Scholar |
| Affiliation |
LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur |
| Address |
OPD no 1 Kayachikitsa Department LRP Ayurvedic medical college
and hospital PG Institute and Research center Urun Islampur
Sangli
MAHARASHTRA
415409
India |
| Phone |
7350517106 |
| Fax |
|
| Email |
ruchaadsul27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhinandan Patil |
| Designation |
Professor |
| Affiliation |
LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur |
| Address |
OPD no 1 Kayachikitsa Department LRP Ayurvedic medical college
and hospital PG Institute and Research center Urun Islampur
Sangli
MAHARASHTRA
415409
India |
| Phone |
9890205000 |
| Fax |
|
| Email |
drabhinandanpatil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhinandan Patil |
| Designation |
Professor |
| Affiliation |
LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur |
| Address |
OPD no 1 Kayachikitsa Department LRP Ayurvedic medical college
and hospital PG Institute and Research center Urun Islampur
Sangli
MAHARASHTRA
415409
India |
| Phone |
9890205000 |
| Fax |
|
| Email |
drabhinandanpatil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Loknete Rajarambapu Patil Ayurvedic medical college hospital post graduate institute and
research center Islampur 415409 |
|
|
Primary Sponsor
|
| Name |
Rucha Vijay Adsul |
| Address |
OPD no 1 Kayachikitsa Department LRP Ayurvedic medical college
and hospital PG Institute and Research center Urun Islampur Tal walawa
Dist Sangli
Maharashtra
India
415409 |
| 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 Rucha Adsul |
LRP Ayurvedic medical college and hospital PG Institute and Research center Urun Islampur 415 409 |
OPD no 1 Kayachikitsa
department
Sangli
MAHARASHTRA |
7350517106
ruchaadsul27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical commitee LRP Ayurvedic medical college and hospital and PCT and RC Approved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rasnadinavak kwath, Reference: Nighantu Ratnakar Amvat chikitsa adhyay, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shunthyadi kwath, Reference: Bhaishajya Ratnavali Amvat chikitsa , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Age 18 to 60 yrs
2 Irrespective of gender & socio-economic status
3 Patients with signs and symptoms of of Amavata like Sandhishool, Sandhishoth,
Sandhistabdhata, Sparshasahatva
4 History of Amavata more than 6 weeks and less than 2 years |
|
| ExclusionCriteria |
| Details |
1 Age below 18 yrs and above 60 yrs
2 Pregnant and lactating mothers
3 Patients with heart diseases, DM, HTN and other Chronic systemic diseases
4 Sandhigata Vata and Vatarakta |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study efficacy of Rasnadinavak Kwath In Amavata |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To study Amavata in detail as per Ayurvedic aspect
2 To study Rasnadinavak Kwath in detail
3 To compare efficacy of trial and control drug |
12 months |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
27/12/2024 |
| 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
|
Amavata is a clinical condition where Ama is stimulated by the aggravated Vata Dosha and Ama settles in Trika Sandhi’s and is characterized by immense pain in joints with inflammation, fever and ultimately stiffness of the joints, causing the temporary or permanent disability of Joints and it hampers daily life activities. Vedas also mention about the various disorders which leads to impairment of movement. But Amavata, as a disease entity is not available even in Brihatrayees. This is first recognized and described in detail by Madhavakara in 9th century. Acharya explained Trika Sandhi or bigger articular joints like knee, elbow etc. as the most prone joints. Prevalence rate of Amavata in india is 0.5% to 1% . Male as to female ratio is 1:3. The substance, which is not properly digested, disintegrated, foul smelling, excessive in quantity, slimy in nature and produces stiffness of the whole body is known as Ama. Not only the food taken in huge quantity but the qualities like Viruddha Ahara, Guru, Ruksha, Vistambhi, Snigdha Ahar and Agnimandata also cause in the production of Ama. Ama and Vata are the two main predominant factors in causing Amavata. When Prakupit Vata and Ama simultaneously enters in the Kostha, Trika and Sandhi leading to stiffness of the body and Trika Sandhi Shool. The symptom like Trishna, Gaurava, Gatrastabdhata, Agnimandya, Apaka, Angamarda, Aruchi and Jwara are found in this disease. In Ayurveda Shamana, Langhana, Swedana, Deepana, and Katu Tikta Dravyas are used for treatment of Amavata. Rasnadinavaka Kwath may prove to be effective and economic in management of Amavata . Hence , Rasnadinavaka Kwath is selected for management of Amavata. |