| CTRI Number |
CTRI/2022/03/041079 [Registered on: 14/03/2022] Trial Registered Prospectively |
| Last Modified On: |
12/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
trial of Shuddha Guggulu in Sandhigatavata w.s.r.Osteoarthritis |
|
Scientific Title of Study
|
“ Randomised Controlled Trial on Shuddha Guggulu in Sandhigatvat WSR to Osteoarthritis Specifically on WOMAC Scale |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rupali Ravindra Kakade |
| Designation |
PG 1st Year |
| Affiliation |
Government Ayurved College,Nagpur |
| Address |
Department of Kayachikitsa,OPD no 1, Government Ayurved College and Hospital, Sakkardara Square,Nagpur
Nagpur
MAHARASHTRA
440029
India |
| Phone |
8999028161 |
| Fax |
|
| Email |
rupalikakade50@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jayant Gulhane |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurved College,Nagpur |
| Address |
Department of Kayachikitsa,OPD no 1, Government Ayurved College and Hospital, Sakkardara Square,Nagpur
Nagpur
MAHARASHTRA
440029
India |
| Phone |
9822922399 |
| Fax |
|
| Email |
jayant.gulhane.62.6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rupali Ravindra Kakade |
| Designation |
PG 1st Year |
| Affiliation |
Government Ayurved College ,Nagpur |
| Address |
Department of Kayachikitsa,OPD no 1, Government Ayurved College and Hospital, Sakkardara Square,Nagpur
Nagpur
MAHARASHTRA
440029
India |
| Phone |
8999028161 |
| Fax |
|
| Email |
rupalikakade50@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved College and Hospital,Nagpur |
|
|
Primary Sponsor
|
| Name |
Government Ayurved College and Hospital |
| Address |
Goverment Ayurved College and Hospital, Sakkardara square, Nagpur |
| Type of Sponsor |
Other [Government Ayurved College and Hospital] |
|
|
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 |
| DrRupali Kakade |
Government Ayurved College and Hospital |
Department of Kayachikitsa, OPD No 1, Government Ayurved College and Hospital, Sakkardara Square, Nagpur
Nagpur
MAHARASHTRA |
8999028161
rupalikakade50@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Ayurved College Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M199||Osteoarthritis, unspecified site. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: shuddha guggulu, Reference: Sushrut Chikitsasthan 6/, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Koshnajal), Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: shallaki, Reference: Bhavprakash Madhyam Khand 24/258, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Koshnajal), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient willing and able to participate in the study.
2) Patients who have not participated in any research projects since last 6 months.
3) Patients presenting with signs and symptoms of Osteoarthrities mentioned in classics.
4) Patients of either sex aged between 30-70years.
5)Patients of Sandhigata Vata presenting clinical features and having symptoms of Sama Vayu described in criteria of diagnosis, will be selected irrespective of sex, caste, religion, socio-economic and educational status. As well as BMI more than 23 will also be taken in to account.
6) Patients willing and able to participate for 6 weeks
7) Controlled systemic disease such as diabetes and hypertension.
|
|
| ExclusionCriteria |
| Details |
1)Immune-compromised patients.
2) Uncontrolled diabetes mellitus and hypertension.
3) Patients with evidence of malignancy.
4) Patients who had undergone major surgery within 2 weeks prior to screening visit.
5) Pregnant and lactating mother.
6) Patients having history of tubercular, gouty and infective arthritis.
7) Patients with any serious life threatening disorder.
8) Any other patient whom investigator feels not to be recruited due any reasons evident at the time of recruitment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effectiveness of Shuddha Guggulu and Shallaki in reducing
WOMAC pain scale of osteoarthritis patient in period of 30 days
|
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the literature of Sandhigat Vata and osteoarthritis as
per modern aspect
|
18 months |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
25/04/2022 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [rupalikakade50@gmail.com].
- For how long will this data be available start date provided 25-04-2022 and end date provided 25-04-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
After
clearance from Institutional Ethics Committee of Government Ayurved college,Nagpur, Patient visited
to OPD, IPD; Casualty with complaints of prasaran akunchan vedana,
shula, shotha, graha ,vatpurnaduti sparsha, agnisad ,tandra, antakujan, vibandh
were recruited from OPD and IPD of Government
Ayurved College, Nagpur.
During the informed
consent process the subjects were given enough time to read patient information
sheet and consent form.(ICF)subjects were also given freedom to ask the
questions and all the questions were answered. If he/she agrees for
participation in the study and if found fit to include during screening
then he was recruited in the study. This visit was called as screening visit.
On screening visit, after
written informed consent, screening of subject on the basis of clinical
assessment for Sandhigatvata (i.e. Osteoarthritis) and fulfilling the
diagnostic criteria . If all inclusion criteria is YES and all exclusion NO
then subjects will be included on the basis of criteria given as Womac Pain Scale
and X-Ray of affected area if necessary
Subjects were then undergo
general and systemic examinations. Clinical symptoms sandhigatvata was assessed along with VAS and
WOMAC scale and recorded in the CRF . Study design will be Parallel Group
Randomised Control Trial .
Parallel
study design of Groups and Drugs Given in Respective Groups
Table-1
|
Group Trial
|
Group Control
|
|
0 Day assessment (Before
treatment) on admission day
|
0 Day assessment (Before
treatment) on admission day
|
|
Shuddha Guggul 500mg BD
|
Shallaki Guggul 500mg BD
|
|
Administrated by oral route
|
Administrated by oral route
|
|
Patient will be instructed
to crush the tablet and not to swallow it
|
Patient will be instructed
to crush the tablet and not to swallow it
|
|
Assessment On 15th
30th day
|
Assessment On 15th 30th
|
|
Collection of data and
analysis
|
Collection of data and
anaylsis
|
Duration of Trial drug: 30 days
Treatment Regimen:
Trial Group
Table-2
|
Treatment given
|
Duration
|
Dose
|
Anupana
|
Bheshaja
Sevankala
|
|
Shuddha Guggulu
|
30 days
|
500mg BD
|
Ushnodak
|
After meals
|
Control Group
Table-3
|
Treatment given
|
Duration
|
Dose
|
Anupana
|
Bheshaja
Sevankala
|
|
Shallaki Guggulu
|
30 days
|
500mg BD
|
Ushnodak
|
After meals
|
|