| CTRI Number |
CTRI/2019/12/022240 [Registered on: 03/12/2019] Trial Registered Prospectively |
| Last Modified On: |
27/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study of enema treatment in the management of osteoarthritis. |
|
Scientific Title of Study
|
A Randomized comparative clinical study to evaluate the effect of Navaprasrutika Basti and Yuktaratha Basti in the management of Sandhigatavata with special reference to Osteoarthritis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shikha Desai |
| Designation |
P.G.Scolar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department of Panchakarma,
Parul Institute of Ayurved,
Parul University,
Po. Limda, Waghodia
Dist. Vadodara-391760
Department of Panchakarma,
Parul Institute of Ayurved,
Parul University,
Po. Limda, Waghodia
Dist. Vadodara-391760
Vadodara
GUJARAT
391760
India |
| Phone |
6353091445 |
| Fax |
|
| Email |
savitadesai.DS@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K B Roy |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department of Panchakarma,
Parul Institute of Ayurved,
Parul University,
Po. Limda, Waghodia
Dist. Vadodara-391760
Department of Panchakarma,
Parul Institute of Ayurved,
Parul University,
Po. Limda, Waghodia
Dist. Vadodara-391760
Vadodara
GUJARAT
391760
India |
| Phone |
9825912141 |
| Fax |
|
| Email |
dr_kbroy@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K B Roy |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Department of Panchakarma,
Parul Institute of Ayurved,
Parul University,
Po. Limda, Waghodia
Dist. Vadodara-391760
Department of Panchakarma,
Parul Institute of Ayurved,
Parul University,
Po. Limda, Waghodia
Dist. Vadodara-391760
Vadodara
GUJARAT
391760
India |
| Phone |
9825912141 |
| Fax |
|
| Email |
dr_kbroy@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Parul Ayurved Hospital, Parul University, Po. Limda, Waghodiya, Vadodara-391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
Department of Panchakarma,
Parul Institute of Ayurved,
Parul University,
Vadodara-391760 |
| 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 Shikha Desai |
Parul Ayurved Hospital |
Department of Panchakarma,
Parul Institute of Ayurved,
Parul University,
Po. Limda, Waghodia
Dist. Vadodara-391760
Vadodara
GUJARAT |
6353091445
savitadesai.DS@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Navaprasrutika Basti |
20 cases of Osteoarthritis treated with Navaprasrutika Basti for 10 days |
| Comparator Agent |
Yuktaratha Basti |
20 cases of osteoarthritis treated with Yuktaratha Basti for 10 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient of grade 1 and 2 of osteoarthritis of knee according to lawrence classification of X-Ray.
Patient fulfilling ACR diagnostic criteria.
Patient between age group of 30-70 years.
Patient of either gender.
Patient fit for Niruha and Anuvasana Basti.
Patient willing for utilization of Aja Mamsa Rasa as Basti Dravya. |
|
| ExclusionCriteria |
| Details |
Any infective condition of the joints.
History of fracture, Trauma and any deformity of knee joint.
Any Chronic systemic and metabolic disease.
Bowel and urine incontinence.
Patients who are contraindicated for Basti.
Patients requiring surgical intervention for the management of osteoarthritis of Knee.
Patient participating in any other clinical study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| reducing of knee joint pain, stiffness. |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reducing in the knee joint pain, stiffness, swelling, restricted movements. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
06/12/2019 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet publish |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Panchakarma is a unique module of management which can eliminate the positive pathogens from the system for complete eradication of disease process, if not only expelled out vitiated Doshas but also pacifies the remaining too. Among the Panchakarma, Basti is considered as superior because of its multidimensional therapeutic effect by mixing with different drugs it will perform the actions like Snehana, Brunhana, Langhana, Samshodhana, Samshamana etc. In Ayurveda Sandhigata Vata is counted under 80 types of Nanatmaja Vyadhis. The chief complaints of patient is Sandhi Shoola, Akunchana Prasarana Vedana, Sandhi Sotha, Sandhi Graha with the similar signs and symptoms of Sandhigata Vata can be comparable with Osteoarthritis. Here Navaprasrutika Basti selected for present study is a type of Niruha that has Vatanashaka effect. The work has been already done on Yuktaratha Basti in the management of Sandhigata Vata. |