| CTRI Number |
CTRI/2020/09/028098 [Registered on: 28/09/2020] Trial Registered Prospectively |
| Last Modified On: |
24/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Pachanarupi Langhana] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the add on effect of Langhana with Panchakolyukta Kulattha Yusha with Singhanada Guggulu in Rheumatoid arthritis |
|
Scientific Title of Study
|
"A Randomized, Controlled Clinical Study Of Add On Effect Of Pachanarupi Langhana With Panchakolyukta Kulattha Yusha With Singhanada Guggulu In The Treatment Of Aama In Aamavata With Special Reference To Rheumatoid Arthritis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Devayani Babhale |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurved college and Hospital Nanded |
| Address |
Kayachikitsa department
Government Ayurved college and Hospital
Vazirabad
Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9527748525 |
| Fax |
|
| Email |
devayanibabhale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Shamshirkhan Pathan |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurved college and Hospital Nanded |
| Address |
Kayachikitsa department
Government Ayurved college and Hospital
Vazirabad
Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9665311877 |
| Fax |
|
| Email |
shamshirkhan680@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Shamshirkhan Pathan |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurved college and Hospital Nanded |
| Address |
Kayachikitsa department
Government Ayurved college and Hospital
Vazirabad
Nanded
MAHARASHTRA
431601
India |
| Phone |
9665311877 |
| Fax |
|
| Email |
shamshirkhan680@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Devayani Babhale |
| Address |
PG student
Kayachikitsa Department
Government Ayurveda College and Hospital
Wazirabad
Nanded |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 |
| Devayani Babhale |
Government Ayurved Hospital |
Kayachikitsa Department
Government Ayurved Hospital
Vazirabad
Nanded
Nanded
MAHARASHTRA |
9527748525
devayanibabhale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Singhanada Guggulu |
Singhanada Guggulu 500mg twice a day for 7days |
| Intervention |
Pachanarupi Langhana with Panchakolyukta Kulattha Yusha with Singhanada Guggulu |
Pachanarupi Langhana with Panchakolyukta Kulattha Yusha 200ml, twice a day for 7days with Singhanada Guggulu 500mg twice a day for 7 days |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the diagnostic criteria of both Aamavata and Rheumatoid arthritis.
Patients between age group of 25 to 50 years.
The patient having history of the disease for about not more than 2 years and having acute attack in last 15 days. |
|
| ExclusionCriteria |
| Details |
Disease duration more than 2year
Severe deformities
Severe ankylosed joints
Patients who are steroid dependent
Alpa bala and alpa satva patients
Patients suffering from other systematic diseases like diabetic melliitus/hepatic/renal/cardiac illness
Pregnant and lactating woman |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the relief in signs and symptoms of aama by Pachanarupi Langhana upakrama
To study the effect of Erythrocyte Sedimentation Rate(ESR) level before and after treatment of aama in Aamavata by Pachanarupi Langhana upakrama |
In 8 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in DAS Score |
8th, 29th, 57th day |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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 3 |
|
Date of First Enrollment (India)
|
02/10/2020 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
The study will be submitted as dissertation as a part of Postgraduate course to Maharashtra University of Health Sciences www.muhs.ac.in |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a Randomized, Controlled Clinical Study of Add on Effect of Pachanarupi Langhana with Panchakolyukta Kulattha Yusha for 7days with Singhanada Guggulu for 8 weeks In The Treatment Of Aama In Aamavata(Rheumatoid arthritis) with followups and assessment of DAS score on 0th, 8th, 29th and 57th days. This is conducted as a compulsory part of PG course at single centre. The primary outcome is reduction is reduction in Aama lakshanaThe secondary outcome is reduction in DAS score The secondary |