| CTRI Number |
CTRI/2023/07/055056 [Registered on: 11/07/2023] Trial Registered Prospectively |
| Last Modified On: |
10/07/2023 |
| 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
|
Effect of Hapushadi Yapan Basti and Kokilaksha Ksheerbasti in Vatrakta (~Gout) – Randomized control trial |
|
Scientific Title of Study
|
Assessment of comparative efficacy of Hapushadi Yapan Basti versus Kokilaksha Ksheerbasti in the management of Vatrakta (~Gout) – Randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonwane Ramesh Dnyanoba |
| Designation |
Ph.D. Scholar |
| Affiliation |
DMIMS, MGACH & RC Salod, Wardha, Maharashtra |
| Address |
C.S.M.S.S. Ayurved Mahavidyalaya & Rugnalya, Kanchanwadi, Aurangabad, Maharashtra
Datta Meghe Institute of Medical Sciences, Mahatama Gandhi Ayurvedic College, Hospital & Research Centre, Salod, Wardha, Maharashtra
Wardha
MAHARASHTRA
431011
India |
| Phone |
9579773404 |
| Fax |
|
| Email |
ramesh10673@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ade Vinod |
| Designation |
Associate Professor and PhD Guide |
| Affiliation |
DMIMS, MGACH & RC Salod, Wardha, Maharashtra |
| Address |
Datta Meghe Institute of Medical Sciences, Mahatama Gandhi Ayurvedic College, Hospital & Research Centre, Salod, Wardha, Maharashtra
Datta Meghe Institute of Medical Sciences, Mahatama Gandhi Ayurvedic College, Hospital & Research Centre, Salod, Wardha, Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9689365368 |
| Fax |
|
| Email |
dr.vinodade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonwane Ramesh Dnyanoba |
| Designation |
Ph.D. Scholar |
| Affiliation |
DMIMS, MGACH & RC Salod, Wardha, Maharashtra |
| Address |
C.S.M.S.S. Ayurved Mahavidyalaya & Rugnalya, Kanchanwadi, Aurangabad, Maharashtra
Datta Meghe Institute of Medical Sciences, Mahatama Gandhi Ayurvedic College, Hospital & Research Centre, Salod, Wardha, Maharashtra
Wardha
MAHARASHTRA
431011
India |
| Phone |
9579773404 |
| Fax |
|
| Email |
ramesh10673@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| DMIMS MGACH RC Salod Wardha Maharashtra |
|
|
Primary Sponsor
|
| Name |
DMIMS MGACH RC Salod Wardha Maharashtra |
| Address |
Datta Meghe Institute of Medical Sciences, Mahatama Gandhi Ayurvedic College, Hospital & Research Centre, Salod, Wardha, Maharashtra |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sonwane Ramesh Dnyanoba |
CSMSS AYURVED MAHAVIDYALAYA |
KANCHANWADI PAITHAN ROAD AURANGABAD MAHARASHTRA
Aurangabad
MAHARASHTRA |
9579773404
ramesh10673@rediffmail.com |
| Dr Sonwane Ramesh Dnyanoba |
DMIMS MGACH &RH Salod Wardha Maharashtra |
Deparament of panchakarma Mahatama Gandhi Ayurvedic College Hospital & Research Centre Salod Wardha Maharashtra
Wardha
MAHARASHTRA |
9579773404
ramesh10673@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
| NOC of CSMSS |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M109||Gout, unspecified. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Charak samhita chikitsa sthana 29/115-116, Procedure details: Madhuk tail matra basti will be given 60 ml to 40 patients for consecutive 7 days after meals (adrapani) after doing sarvanga snehana and swedana. Tadan, bastipratyagaman and aharvyavastha will be done after basti karma.)
(1) Medicine Name: Madhuk taila matra basti, Reference: Chark samhita chikitsa sthana 29/115-116, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Charak samhita siddhi sthana 12/16(7), Procedure details: Hapushadi yapan basti 960 ml will be given for 8 days consecutively to each patient empty stomach (abhukta kala) after sarvanga snehana and swedana. After basti Tadan, basti pratyagaman, aharvyavastha will be done.)
(1) Medicine Name: Hapushadi yapan absti, Reference: Charak samhita siddhi sthana 12/16(7), Route: Rectal, Dosage Form: Ksheerpaka, Dose: 960(ml), Frequency: od, Duration: 8 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient showing signs and symptoms of vatarakta (gouty arthritis)
Age group between 20 to 70 years
Patient willing for written consent
Patient indicated for basti
Patient with elevated uric acid level |
|
| ExclusionCriteria |
| Details |
Patients diagnosed with any other systemic illness which are fatal and chronic in nature
Below 20 and above 70 years old patients
Known case of ulcers or ulcerativecolitis
Basti Ayogy(patient unfit for Basti chikitsa)
Pregnant woman
|
|
|
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 |
Serum uric acid
sign and symptoms of Vatarakata |
24 days with followup baseline and on 8th & 24th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sandhishoola (Pain in joints),
. Sparshasahatva (Tenderness of joints) ,
Sandhidaha (Burning sensation in joints),
Sandhigraha (stiffness in joints).
Angavaikalya (Deformity of joints)
Sr. uric acid
Sandhishotha (joint circumference for assess swelling).
|
24 days with follow up basline and on 8th & 21th day |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
18/07/2023 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In Ayurveda Vatrakta has been explained as a condition which is caused by involvement of vata dosha and rakta dhatu. It can be correlated to Gout. It has predominant symptoms like severe joint pain with onset at Karpada Anguli and in later satge the vitiated vata spreads to all over body manifesting other symptoms like toda, ushnata, vaivarnyata etc. Prevalance of gout is 1-4% in general population which is commom in both elderly gender. As per Ayurveda, Panchakarma is quite effective in its management. Out of which Basti is easier, cost effective and comfortable treatment. Basti is considered as Ardha chikitsa and sarvahar. Hapushadi Yapan Basti is effective on vatrakta, weakness due to excessive vyavay (intercourse), all type of vata vyadhi and increases buddhi, dharana shakti and agni (digestive power). |