| CTRI Number |
CTRI/2019/03/018021 [Registered on: 11/03/2019] Trial Registered Prospectively |
| Last Modified On: |
26/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Rasnadi Guggul and Shallaki in management of Sandhigat vata(Osteoarthritis) |
|
Scientific Title of Study
|
“A COMPARATIVE CLINICAL STUDYOF RASNADI GUGGUL AND SHALLAKI IN MANAGEMENT OF SANDHIGAT VATAâ€
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rupali Khobragade |
| Designation |
Associate Lecturer |
| Affiliation |
CARC, Nigdi Pradhikaran, Pune |
| Address |
PDEAs College of Ayurved and Research Centre, sector 25, Nigdi Pradhikaran, Pune
Ayurveda Rugnalaya
Department - kayachikitsa
opd no.-117 , Sector-27 , Nigdi Pradhikaran , Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8378929859 |
| Fax |
|
| Email |
khobragaderupali19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rupali Khobragade |
| Designation |
Associate Lecturer |
| Affiliation |
CARC, Nigdi Pradhikaran, Pune |
| Address |
PDEAs College of Ayurved and Research Centre, sector 25, Nigdi Pradhikaran, Pune
Ayurved Rugnalaya
Department - kayachikitsa
opd no. -117 , Sector-27, Nigdi Pradhikaran , Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8378929859 |
| Fax |
|
| Email |
khobragaderupali19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Smita Gharge |
| Designation |
PG student |
| Affiliation |
CARC, Nigdi Pradhikaran |
| Address |
PDEAs College of Ayurved and Research Centre, sector 25, Nigdi Pradhikaran, Pune
Ayurveda Rugnalaya
Department -kaychikitsa
opd no.117 , sector-27 , Nigdi Pradhikaran , Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8356060563 |
| Fax |
|
| Email |
smitagharge02@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre, sector 25, Nigdi Pradhikaran, Pune |
|
|
Primary Sponsor
|
| Name |
CARC Nigdi Pradhikaran |
| Address |
PDEAS College of Ayurved and Research Centre, sector 25, Nigdi Pradhikaran, Pune |
| Type of Sponsor |
Private medical college |
|
|
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 Rupali Khobragade |
CARC College |
PDEAs College of Ayurved and Research Centre sector 25 Nigdi Pradhikaran Pune
Pune
MAHARASHTRA |
8378929859
khobragaderupali19@gmail.com |
| Dr Rupali Khobragade |
CARC Hospital |
Ayurved Rugnalaya Kayachikitsa department OPD 117 near bhel chowk Nigdi Pradhikaran Pune
Pune
MAHARASHTRA |
8378929859
khobragaderupali19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
| MUHS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M159||Polyosteoarthritis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Rasnadi guggul 500 mg |
Rasnadi guggul will be made in pharmacy and standardisation will be done from recognised institute. Rasnadi guggul 500 mg 2tabs twice a day for 45 days |
| Comparator Agent |
Tab shallaki 400 mg |
Tab shallaki will be obtained from reputed company and standardisation will be obtained from same for 45 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with osteoarthritis(Sandhigat vata)
1)Age: 30 years to 70 years of age
2)Gender: Male & female
3)Signs and symptoms of pain, swelling, crepitus, tenderness, stiffness, painful movements etc.
4)Patients without any anatomical deformity. |
|
| ExclusionCriteria |
| Details |
1)Patients below 30 years and above 70 yrs of age.
2)Patients suffering from uncontrolled diabetes, Rheumatoid arthritis, Gouty arthritis, Psoriatic arthritis, Systemic lupus erythematosus, Bone TB, injuries and other systemic disorders etc. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rasnadi guggul 500mg 2 tabs twice a day in the management of Sandhigat Vata (Osteoarthritis) for 45 days |
Rasnadi guggul 500 mg 2tabs twice a day for 45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of shallaki in management of Sandhigat Vata ( Osteoarthritis) |
To assess the efficacy of Rasnadi guggul in the management of Sandhigat Vata ( Osteoarthritis) for duration of 45 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
15/03/2019 |
| 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="0"
Months="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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)?
|
|
Brief Summary
|
Sandhigat vata (Osteoarthritis) is one of the degenerative diseases nowadays. Osteoarthritis is the most prevalent and leading cause of pain and disability in most countries worldwide. Our ancient Acharyas of Ayurveda explained various important properties of Herbal drugs in Samhitas & Nighantus. Ayurved has many treatment options for Osteoarthritis. With the help of this topic, we are going to assess the effect of the Rasnadi guggul and Shallaki on essential Sandhigat vata. Though the prevalence of sandhigat vata is increasing constantly, there is less previous research work done in Ayurveda as compared to prevalence. So this is the humble attempt to do research work with Rasnadi guggul and Shallaki on Sandhigat vata which may be useful to overcome this problem. If these treatments can be started at the beginning of the symptoms, the degeneration can be prevented. |