trial of Shuddha Guggulu in Sandhigatavata w.s.r.Osteoarthritis
- Conditions
- Osteoarthritis, unspecified site. Ayurveda Condition: SANDHIGATAVATAH,
- Registration Number
- CTRI/2022/03/041079
- Lead Sponsor
- Government Ayurved College and Hospital
- Brief Summary
Afterclearance from Institutional Ethics Committee of Government Ayurved college,Nagpur, Patient visitedto 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 GovernmentAyurved College, Nagpur.
During the informedconsent process the subjects were given enough time to read patient informationsheet and consent form.(ICF)subjects were also given freedom to ask thequestions and all the questions were answered. If he/she agrees forparticipation in the study and if found fit to include during screeningthen he was recruited in the study. This visit was called as screening visit.
On screening visit, afterwritten informed consent, screening of subject on the basis of clinicalassessment for Sandhigatvata (i.e. Osteoarthritis) and fulfilling thediagnostic criteria . If all inclusion criteria is YES and all exclusion NOthen subjects will be included on the basis of criteria given as Womac Pain Scaleand X-Ray of affected area if necessary
Subjects were then undergogeneral and systemic examinations. Clinical symptoms sandhigatvata was assessed along with VAS andWOMAC scale and recorded in the CRF . Study design will be **Parallel GroupRandomised Control Trial** .
**Parallelstudy 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 88
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the effectiveness of Shuddha Guggulu and Shallaki in reducing 18 months WOMAC pain scale of osteoarthritis patient in period of 30 days 18 months
- Secondary Outcome Measures
Name Time Method To study the literature of Sandhigat Vata and osteoarthritis as per modern aspect
Trial Locations
- Locations (1)
Government Ayurved College and Hospital
🇮🇳Nagpur, MAHARASHTRA, India
Government Ayurved College and Hospital🇮🇳Nagpur, MAHARASHTRA, IndiaDrRupali KakadePrincipal investigator8999028161rupalikakade50@gmail.com