FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/06/069170 [Registered on: 19/06/2024] Trial Registered Prospectively
Last Modified On: 07/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   An Ayurvedic Treatment for Management of Osteoarthritis in the elderly people. 
Scientific Title of Study   To Compare The Efficacy Of Devdarubaladi Taila And Balasaireyaka Taila For Matra Basti In The Management Of Janu Sandhigatavata Osteoarthritis Of Knee Joint An Open Labelled Randomized Clinical Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priyanka Rathva 
Designation  pg scholar 
Affiliation  Government Akhandanand Ayurved College And Hospital, Bhadra, Ahmedabad, Gujarat, India 380001 
Address  Opd no 5, Government Akhandanand Ayurved College And Hospital, Bhadra, Ahmedabad, Gujarat, India 380001

Ahmadabad
GUJARAT
380001
India 
Phone  7096511926  
Fax    
Email  piyurathva93@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rohini Salve 
Designation  Associate Professor 
Affiliation  Government Akhandanand Ayurved College And Hospital, Bhadra, Ahmedabad, Gujarat, India 380001 
Address  Opd no 5, Government Akhandanand Ayurved College And Hospital, Bhadra, Ahmedabad, Gujarat, India 380001

Ahmadabad
GUJARAT
380001
India 
Phone  9313001450  
Fax    
Email  rohinirakesh2@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rohini Salve 
Designation  Associate Professor 
Affiliation  Government Akhandanand Ayurved College And Hospital, Bhadra, Ahmedabad, Gujarat, India 380001 
Address  Opd no 5, Government Akhandanand Ayurved College And Hospital, Bhadra, Ahmedabad, Gujarat, India 380001

Ahmadabad
GUJARAT
380001
India 
Phone  9313001450  
Fax    
Email  rohinirakesh2@gmail.com  
 
Source of Monetary or Material Support  
Government Akhandanand Ayurved College And Hospital, Ahmedabad, Gujarat, India. 380001 
 
Primary Sponsor  
Name  Government Akhandanand Ayurved College And Hospital 
Address  Opd no 5, Government Akhandanand Ayurved College And Hospital, Bhadra, Ahmedabad, Gujarat, India 380001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Priyanka Rathva  Government Akhandanand Ayurved college and hospital  opd no 5, Government Akhandanand Ayurved college and hospital, bhadra, ahmedabad, gujarat, india 380001
Ahmadabad
GUJARAT 		 7096511926

piyurathva93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Akhandanand Ayurved College and Hospital Institutional Ethical Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-svedanam, स्वेदनम् (Procedure Reference: charaka samhita, Procedure details: Sweadana – Nadi Sweda)
2Intervention ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: Charak Samhita, Procedure details: Abhayang- Udara, Kati, Ubhaya Pada Pradeshe with Nirgundi Taila)
3Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः Pradhan Karma(Procedure Reference: charaka Samhita, Procedure details: Drug: Devdarubaladi Taila • Dose: 60 ml • Dosage form: Taila • Basti pradan kal: Immediately after meal (At noon) •Route of administration: Ano-rectal route •Follow up: Follow up study will be done for the period of 2 weeks after completion of treatment at an interval of 1 week.)
4Comparator ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: charaka Samhita, Procedure details: Drug: Balasaireyaka Taila • Dose: 60 ml • Dosage form: Taila • Basti pradan kal: Immediately after meal (At noon) • Route of administration: Ano-rectal route •Follow up: Follow up study will be done for the period of 2 weeks after completion of treatment at an interval of 1 week.)
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients presenting with the classical signs and symptoms of Sandhigata Vata (OA) according to Ayurveda as well as Modern science.
Patients of age more than or equal to 40 years to less than or equal to 70 years of age.
Patient is indicated for Snehana and Swedana.
Patients indicated for Basti Karma.
 
 
ExclusionCriteria 
Details  Patients less than or equal to 40 years and more than or equal to 70 years of age.
Known cases of Gout, Rheumatoid Arthritis, Systemic Lupus Erythematous (SLE), Bone TB, Traumatic injuries, Infective arthritis and other serious systemic disorder.
Patient is not indicated for Snehana and Swedana.
Patient is unfit for Matra Basti (eg. Raktarsha , Bhagandar etc.)
Patient having history of knee joint replacement. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
to improve the disability produced by osteoarthritis  follow up will for weekly for 2 week 
 
Secondary Outcome  
Outcome  TimePoints 
to improve quality of life of patient  follow up will for weekly for 2 week 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/07/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

RESEARCH QUESTION :

Is there any significant difference in the efficacy of Devdarubaladi Taila Matra Basti and Balasaireyaka Taila Matra Basti in the management of Janu Sandhigata Vata (Osteoarthritis of knee joint)?

 

HYPOTHESIS:

NULL HYPOTHESIS(H0): Devdarubaladi Taila Matra Basti and Balasaireyaka Taila Matra Basti has same effect in management of Janu Sandhigata Vata (Osteoarthritis of knee joint).

ALTERNATIVE HYPOTHESIS (H1): Devdarubaladi Taila Matra Basti is more effective than Balasaireyaka Taila Matra Basti in the management of Janu Sandhigata Vata (Osteoarthritis of knee joint).

ALTERNATIVE HYPOTHESIS (H2): Devdarubaladi Taila Matra Basti is less effective than Balasaireyaka Taila Matra Basti in the management of Janu Sandhigata Vata (Osteoarthritis of knee joint).

 

AIM:

To evaluate and compare the efficacy of Devdarubaladi Taila Matra Basti and Balasairayaka Taila Matra Basti in the management of Janu Sandhigata Vata (osteoarthritis of knee joint).

 

OBJECTIVES:

Ø  To study the etiopathogenesis of Janu Sandhigata Vata according to Ayurveda as well as Modern aspect.

Ø  To study Matra Basti according to all Ayurvedic texts.

Ø  To study the effect of Devdarubaladi Taila Matra Basti and Balasaireyaka Taila Matra Basti in the management of Janu Sandhigata Vata (osteoarthritis of knee joint).

Ø  To compare the effect of Devdarubaladi Taila Matra Basti and Balasaireyaka Taila Matra Basti in the management of Janu Sandhigata Vata (osteoarthritis of knee joint).

 

DIAGNOSTIC CRITERIA:

• SUBJECTIVE CRITERIA:

Patients having classical signs and symptoms of the Sandhigata Vata according to Ayurveda as well as Modern science will be taken into consideration.

Ø  Vatpurna Druti Sparsh,

Ø  Shotha (joint swelling)

Ø  Akunchan Prasarne vedana,

Ø  Sandhi Shoola (joint pain),

Ø  Joint Stiffness

Ø  Crepitus.

 

• OBJECTIVE CRITERIA :

Ø  Patient with radiological features suggestive of Osteoarthritis of knee joint like reduction of Joint space, Osteophytes formation, Loose bodies, Osteoporosis. 

CRITERIA FOR SELECTION OF PATIENT:                                                                                  Patient will be selected irrespective of caste, gender, profession etc. from O.P.D. and I.P.D. of Govt. Akhandanand Ayurveda Hospital, Ahmedabad and Govt. Maniben Ayurveda Hospital, Ahmedabad.

INCLUSION CRITERIA:

Ø  Patients presenting with the classical signs and symptoms of Sandhigata Vata (OA) according to Ayurveda as well as Modern science.

Ø  Patients of age ≥40 to ≤70 years.

Ø  Patient is indicated for Snehana and Swedana.[i]

Ø  Patients indicated for Basti Karma.

EXCLUSION CRITERIA:

Ø Patients ≤ 40 years and ≥ 70 years of age.

Ø Known cases of Gout, Rheumatoid Arthritis, Systemic Lupus Erythematous (SLE), Bone TB, Traumatic injuries, Infective arthritis and other serious systemic disorder.

Ø Patient is not indicated for Snehana and Swedana.

Ø Patient is unfit for Matra Basti (eg. Raktarsha , Bhagandar etc.)

Ø Patient having history of knee joint replacement.

 

 

 

STUDY DESIGN:

Ø STUDY TYPE      : Open Labelled Randomized Clinico Comparative Trail

Ø BLINDING            : Open label

Ø COMPARATIVE  : Yes

Ø NO. OF GROUP : 2

GROUP-1: Will be treated with Devdarubaladi Taila Matra Basti.

GROUP-2: Will be treatd with Balasaireyaka Taila Matra Basti.

Ø SAMPLE SIZE     : Minimum 15 patients will  be  include  in each group.

Ø LOCATION OF STUDY : Study will be conducted at Government Akhandanand  Ayurved Hospital ,Ahmedabad and Maniben Ayurved Hospital.

 

The patients will be randomly divided into two groups irrespective of their Age, Gender, Religion and Occupation.

Group-A : Devdarubaladi Taila Matra Basti for 15 days.

Group-B: Balasaireyaka Taila Matra Basti for 15 days.

INVESTIGATIONS:

Ø  Haematological examination: HB%, CBC (Both B.T. and A.T.), ESR

Ø  RBS, RA, Uric Acid (To rule out other pathologies).

Ø  Radiological Assessment: Plain X-ray AP and Lateral view- standing position (Both B.T. and A.T.).

 

WITHDRAWAL CRITERIA:

After the scheduled course, medicines will be withdrawan  with proper consultation and future follow up will be maintained. During the trail period, if any moderate to severe complications found, medication will be stopped.

 CRITERIA FOR ASSESSMENT:

Ø By observing clinical improvement in signs and symptoms of disease mentioned in Ayurvedic classics as well as modern texts.

Ø To assess the effect of therapy objectively, all the signs and symptoms like Sandhishula, Sandhishotha , Akunchan prasarne Vedana,  Sandhisphutuna (Crepitation) will be subjected to given scoring patterns.

Ø Assessment will be done before treatment and after completion of entire treatment.

 

REPORTING A.D.R:

Adverse Drug Reaction (ADR), if observed will be registered and reported to Peripheral Pharmacovigilance Center (PPvC), GAAC, Ahemdabad.

 

STATISTICAL ANALYSIS:

Assessment will be done on the basis of special proforma through scoring pattern and will be analysed statistically with help of “t” test and Willcoxon signed-rank test. where > 0.05=insignificant result, < 0.05 = significant result and < 0.001= highly significant result. 

STANDARD PROFORMA:

Standard proforma will be developed and used in the study to evaluate the comparative efficacy of the trail drug.

PRESENTATION OF DATA: The data collected, analysed will be depicted as general observations viz. age, sex, religion etc. The results of individual investigations will be presented by a proper bar diagram, pie diagram etc.

DISCUSSTION AND CONCLUSION:

After getting all the data, discussion and conclusion will be done as per the observations and results.

COLLABORATION REQUIRED: With other Department

Department of RSBK, Dravyaguna and Roganidan-Vikruti Vigyan Department Government Akhandanad  Ayurved Collage, Ahmedabad.

DECLARATION: The study will be completed in the stipulated time limit. The work will be carried out after getting clearance from the institutional ethics committee. The data related to the identification of the patient will be kept confidential. The clinical data obtained will be summarized at the end of the study.



 
Close