| CTRI Number |
CTRI/2023/06/054110 [Registered on: 19/06/2023] Trial Registered Prospectively |
| Last Modified On: |
16/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Trial to study the effect of tablet Vyoshadi guggulu along with the Vaitarana Basti protocol in Rheumatoid Arthritis. |
|
Scientific Title of Study
|
Clinical evaluation of Vyoshadi guggulu with Vaitarana Basti in the management of Amavata (Rheumatoid Arthritis): A Controlled Clinical study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nagashree N |
| Designation |
Postgraduate Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Bengaluru |
| Address |
Department of PG studies in Kayachikitsa,
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalgodu post, Bengaluru, Karnataka
Bangalore
KARNATAKA
560074
India |
| Phone |
8217862736 |
| Fax |
|
| Email |
nagashreen@sdmayurbangalore.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srinivasa S |
| Designation |
Professor and Head of the Department |
| Affiliation |
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Bengaluru |
| Address |
Department of PG studies in Kayachikitsa,
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalgodu post, Bengaluru, Karnataka
Bangalore
KARNATAKA
560074
India |
| Phone |
9448211053 |
| Fax |
|
| Email |
ssomayaji78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nagashree N |
| Designation |
Postgraduate Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Bengaluru |
| Address |
Department of PG studies in Kayachikitsa,
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalgodu post, Bengaluru, Karnataka
Bangalore
KARNATAKA
560074
India |
| Phone |
8217862736 |
| Fax |
|
| Email |
nagashreen@sdmayurbangalore.in |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalgodu post, Bengaluru-560074 |
|
|
Primary Sponsor
|
| Name |
Dr Nagashree N |
| Address |
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalgodu post, Bengaluru, Karnataka |
| Type of Sponsor |
Other [] |
|
|
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 Nagashree N |
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Bengaluru |
Out Patient Department of Kayachikitsa and Panchakarma, Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalgodu post, Bengaluru, Karnataka
Bangalore
KARNATAKA |
08217862736
nagashreen@sdmayurbangalore.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Kumbalgodu post, Bengaluru. |
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: Vyoshadi Guggulu, Reference: Ashtanga Hridaya, Chikitsasthana 21/50, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 31 Days, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: - | | 2 | Intervention Arm | Procedure | - | vaitaraNa-bastiH, वैतरण-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Chakradatta, Niruhadhikara 73/33-34, Procedure details: 1. Vaitarana Basthi- Vaitarana basti Protocol in the Yoga Basti pattern which includes alternate 5 Anuvasana basthi with Bruhat Saindhavadi taila and 3 Niruha basti, starting from Anuvasana basti is given on consecutive days respectively ending with two Anuvasana basti for about 8 days (From Day 8- Day 15 of the trial period).)
| | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Simhanada Guggulu, Reference: Bhiashajya rathnavali, Amavatadhikara, 130-131, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 31 Days, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: - | | 4 | Comparator Arm | Procedure | - | vaitaraNa-bastiH, वैतरण-बसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Chakradatta, Niruhadhikara 73/33-34., Procedure details: 1. Vaitarana Basthi- Vaitarana basti Protocol in the Yoga Basti pattern which includes alternate 5 Anuvasana basthi with Bruhat Saindhavadi taila and 3 Niruha basti, starting from Anuvasana basti is given on consecutive days respectively ending with two Anuvasana basti for about 8 days (From Day 8- Day 15 of the trial period).)
|
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|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
American College of Rheumatology/ European League against Rheumatism classification criteria for Rheumatoid Arthritis 2010, Subjects who fulfills a score of greater than or equal to 6/10 with Duration of symptoms greater than or equal to 6 weeks and Lesser than or equal to 10 years. |
|
| ExclusionCriteria |
| Details |
Subjects,
1.On drug therapy such as DMRAD’s.
2.With Severe joint deformity.
3.Diagnosed with Spine, Gout, Ankylosing spondylosis, Osteoarthritis, Traumatic arthritis, Psoriatic arthritis, Infective Arthritis, Septic arthritis and Pyogenic Osteomyelitis.
4.With associated co-morbidities such as Cardiac disease, Pulmonary Tuberculosis, Uncontrolled Diabetes Mellitus, Malignant Hypertension, Renal Function Impairment.
5.Pregnant and Lactating Women.
6.Contraindicated for Basthi procedure. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Simple Disease Activity Index (SDAI) of Rheumatoid Arthritis.
2.Pratyatma Lakshanas Of Amavata.
|
Day-0 & Day-32 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| QoL- RA (Quality of Life- Rhematoid Arthritis) Questionnaire |
Day-0 & Day-32 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
25/06/2023 |
| 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
|
NIL |
|
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 Open label Controlled Clinical trial to evaluate the Combined Clinical effect of Vyoshadi Guggulu along with Vaitarana Basti protocol in the Disease Activity of Rheumatoid arthritis. Subjects are allocated in to study and control groups respectively. Study group includes 15 subjects Qualifying the Inclusion Criteria of the current study with Oral administration of Tab. Vyoshadi guggulu 500mg TID with lukewarm water After food for 31 days starting from Day-1 of the trial along with Vaitarana basti Protocol in the Yoga Basti pattern which includes alternate 5 Anuvasana basthi with Bruhat Saindhavadi taila and 3 Niruha basti, starting from Anuvasana basti which is given on consecutive days respectively ending with two Anuvasana basti for about 8 days (From Day 8- Day 15 of the trial period). Control group includes 15 subjects Qualifying the Inclusion Criteria of the current study with Oral administration of Tab. Simhanada guggulu 500mg TID with lukewarm water After food for 31 days starting from Day-1 of the trial along with Vaitarana basti Protocol in the Yoga Basti pattern which includes alternate 5 Anuvasana basthi with Bruhat Saindhavadi taila and 3 Niruha basti, starting from Anuvasana basti which is given on consecutive days respectively ending with two Anuvasana basti for about 8 days (From Day 8- Day 15 of the trial period). The Primary Outcome measure will be Simple Disease Activity Index (SDAI) of Rheumatoid Arthritis after 31 days. The Secondary Outcome measure will be QoL- RA (Quality of Life- Rhematoid Arthritis) Questionnaire after 31 days. |