| CTRI Number |
CTRI/2024/11/076665 [Registered on: 12/11/2024] Trial Registered Prospectively |
| Last Modified On: |
08/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study the efficacy Of Gomutradi siddha Basti in the management of Amavata (Rheumatism due to ama) |
|
Scientific Title of Study
|
Randomized controlled clinical trial to study the efficacy of Gomutradi siddha basti in the management of Amavata (Rheumatism due to ama) |
| 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 Shubhangi Parmeshwar Thombare |
| Designation |
PG Scholar |
| Affiliation |
C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 |
| Address |
OPD No 15 Panchakarma Department C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011
Aurangabad MAHARASHTRA 431011 India |
| Phone |
9850738496 |
| Fax |
|
| Email |
shubhangithombare94@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ramesh Dnyanoba Sonwane |
| Designation |
Associate Professor |
| Affiliation |
C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 |
| Address |
OPD No 15 Panchakarma Department C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011
Aurangabad MAHARASHTRA 431011 India |
| Phone |
9579773404 |
| Fax |
|
| Email |
ramesh10673@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shubhangi Parmeshwar Thombare |
| Designation |
PG Scholar |
| Affiliation |
C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 |
| Address |
OPD No 15 Panchakarma Department C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011
Aurangabad MAHARASHTRA 431011 India |
| Phone |
9850738496 |
| Fax |
|
| Email |
shubhangithombare94@gmail.com |
|
|
Source of Monetary or Material Support
|
| C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 |
|
|
Primary Sponsor
|
| Name |
C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 |
| Address |
C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 |
| 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 Shubhangi Parmeshwar Thombare |
C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431001 |
OPD No 15 Panchakarma Department C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra Aurangabad MAHARASHTRA |
9850738496
shubhangithombare94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CSMSS Ayurved Mahavidyalaya and Rugnalaya, Aurangabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M00-M99||Diseases of the musculoskeletal system and connective tissue. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma, बसà¥à¤¤à¤¿à¤•रà¥à¤® | (Procedure Reference: Charak Samhita, Procedure details: Patient will be asked to lie down on droni (table) in vamaparshwa stithi i.e. left lateral position.
420 ml sukhoshna i.e. warm Gomutradi siddha basti will be taken in basti yantra for Niruha basti.
60 ml of warm Bruhatsaindhavadi taila will be taken for Anuvasan basti.
Anus will be made lubricated with taila.
Basti will be given by applying the appropriate pressure on basti putaka.) (1) Medicine Name: Gomutradi Siddha Basti, Reference: Vangasen Samhita, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 420(ml), Frequency: od, Duration: 8 Days | | 2 | Comparator Arm | Procedure | - | bastikarma, बसà¥à¤¤à¤¿à¤•रà¥à¤® | (Procedure Reference: Charak samhita siddhi sthan, Procedure details: Patient will be asked to lie down on droni (table) in vamaparshwa stithi i.e. left lateral position. 420 ml sukhoshna i.e. warm Ardhamatrik basti will be taken in basti yantra for Niruha basti. 60 ml of warm Bruhatsaindhavadi taila will be taken for Anuvasan basti. Anus will be made lubricated with taila. Basti will be given by applying the appropriate pressure on basti putaka.)) (1) Medicine Name: Ardhamatrik basti, Reference: Chakrapanidatta, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 420(ml), Frequency: od, Duration: 8 Days |
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with signs & symptoms of Amavata mentioned in Ayurved classics.
Patients with seropositive seronegative results of RA factor.
Patients irrespective of their age, genders.
Basti Yogya Rugna. |
|
| ExclusionCriteria |
| Details |
Basti Ayogya Rugna.
Rheumatoid Arthritis associated with -
Pregnancy
SLE
Any critical systemic diseases. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sandhi shoola (pain in joints), Sandgi/Gatra stabdhata (morning stifness) will be reduced. |
8 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gaurava (heaviness), Aruchi (tastelessness), Sparshasahatva (tenderness in joints) |
8 days |
|
|
Target Sample Size
|
Total Sample Size="92" Sample Size from India="92"
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)
|
20/11/2024 |
| 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
|
Amavata (Rheumatoid Arthritis) is a disease with variety of symptoms whose characteristic symptom is "persistent inflammatory synovitis" usually involving peripheral joints showing pain, swelling and tenderness. Where pain in affected joints gets aggravated by movement. The majority of patients experiences constitutional symptoms such as weakness, easy fatigability, anorexia & weight loss. For all such conditions, Ayurveda has described various Panchakarma procedures, out of which Basti chikitsa is advised mainly for Vatadosha pradhan vyadhis (diseases due to vitiated vatadosha). Overall taken drugs in this study being Deepana will improve Agni (digestive fire) which leads to absorption of Aama and also purifies vitiated vata dosha. Study will be conducted on 92 diagnosed patients of Amavata (Rheumatoid Arthritis). Written consent will be taken. Initial Assessment will be done. Patient will be treated with Interventional Group Gomutradi siddha basti and Control group Ardhamatrik basti. Patient will be assessed at follow up. Observation and result will be noted and statistical analysis, discussion and conclusion will be done.
Null Hypothesis (H0): Gomutradi Siddha basti is not effective in management of (Rheumatism due to Ama).
Alternate Hypothesis (H1): Gomutradi Siddha Basti is effective in the management of Amavata (Rheumatism due to Ama). |