1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   
   
3. 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.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [dr.waseemrahmani09@gmail.com].
   


6. For how long will this data be available start date provided 03-06-2024 and end date provided 03-06-2025?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Present study entitled “A comparative clinical study to evaluate the effectiveness of suddha guggulu and suddha salai guggulu in case of janugatasandhivata” (w.s.r. to Knee Osteo-arthritis)

AIMS AND OBJECTIVE

1.      To assess the efficacy of trial drugs in the management of janugata Sandhigata vata.

2.      To compare the efficacy of Guggulu and Salai guggulu in the management of janugata Sandhigat vata.

3.      To observe clinical improvement if any/prognosis/recurrence of symptoms during the follow up period.

4.      To assess the side effect of trial drugs if any.

PLAN OF STUDY

i) SELECTIONOF CASES :

·        For purpose of this clinical trials, patients of Janugat Sandhivata will be selected regardless of Sex, occupation and Socio-economic conditions with the age group of 41-70 years from the Kaya chikitsa O.P.D and I.P.D. of State Ayurvedic College and Hospital, Lucknow and the referred cases which fulfil criteria will also be included.

·        After a careful clinical history, examination and lab investigation as per proforma patient will be selected and screened for their suitability of getting enrolled in the clinical trial as per specific inclusion and exclusion criteria.

ii) INCLUSION CRITERIA:

·        Patient who give the consent to participate in study.

·        Patient of age group 41-70 years.

·        Patient fulfilling the diagnostic criteria as per clinical proforma.

·        The Patients who will be agree to stop all the previous medications of Osteoarthritis.

After diagnosis is established the patient will be included for clinical trial.

CRITERIA FOR SELECTION OF CASES:

The diagnosis of Sandhivata patients enrolled in this study will be on the basis of clinical and radiological finding as follows: -

a) Clinical Findings:

The criteria for selection of cases is made on the basis of the cardinal sign and symptoms given in various Ayurvedic texts and in modern texts are kept in consideration, where the sign and symptoms of Sandhivata and O.A. are given as follows:-

Major Criteria

1. वातपूर्णदृतिस्पर्श (Crepitus)

2. सन्धिशूल (Pain in or around the knee joint)

3. प्रसारणाकुन्चनयोप्रवृत्तिश्चसवेदना (Painful flexion and extension of knee joint)

4. हन्तिसन्धि (Restricted range of movement of knee joints)

5. (Oedema)

Minor Criteria

1. Tenderness of knee joints

2. Morning stiffness (< half an hour)

3. सन्धि शोफ (Synovial effusion)

4. Increased walking time

b) Radiological findings:

X-ray of the affected joints areas showing…..

1. Osteophytes (Bony swelling)

2. Reduced joint space

3. Subchondral bone sclerosis

4. Osteoporosis

5. Bone fragility

Patient having 3 or more than 3 major criteria and any 1 minor criteria along with at least 1 of above radiological finding will be register for the present clinical trial. We will also assist the sign and symptoms of sandhigatavata in comparison to ACR criteria for classification and reporting osteoarthritis of knee joints.

ACR Revised criteria for early diagnosis of Knee Osteoarthritis 2016

Enty Criteria :

- Knee pain and/or knee bony tenderness.

- Absence of exclusion criteriab.

Domain I :

-         Mechanical Knee painc

-         Knee bony tenderness

-         Crepitus on Knee motion

-         Compatible synovial fluid

Domain II :

-         40< Age at onset < 50 years old

-         Age at onset > 50 years old

-         Knee bony enlargemente

-         Osteophytes in knee X-Ray or compatible knee MRI

a)     In the presence of 3 points outof 10 with at least 1 point from Domain II along with all entry criteria, the diagnosis of Knee OA can be established.

b)     Exclusion criteria are including:1) moderate to significant Knee synovitis 2) hot or red Knee 3) history and /or physical examination findings compatible with the internal derangement of knee.

c)     Knee pain that is initiated or increased with knee activity/ exercise and finished or decreased with knee resting.

d)     Clear fluid with normal viscosity accompanied by WBC count less than 2000/mm3 with less than 25% PMN.

e)     It must be ignored in the presence of osteophyte in the knee x-ray.

f)      (Ref. Iraj Salehi-(2016), 2016 ACR Revised criteria for diagnosis of knee osteoarthritis, autoimmune dis ther approaches 3:118)

INVESTIGATIONS

Few investigations will also be made for better assessment of disease severity and patients general condition as listed below –

A) Laboratory Investigation –

Blood:Routine: Hb%,CBC,B.Sugar (Fasting-PP)

Specific: E.S.R., R.A. factor, S. Uric acid, S. Calcium,

BMD Test, Vita D3, Thyroid profile (if required)

B) Radiological Investigation –

X- Ray Knee joints – AP/ Lateral view

MRI- knee joint (if required)

iii) EXCLUSION CRITERIA:

1. Age below 41 years and above 70 years will be excluded.

2. Unwilling patient will be excluded.

3. Cases having severe joints deformities like Heberden node etc. will be excluded.

4. Cases with complications like severe ankylosed Joints and with infective joints disorders (Osteomyelitis), moderate to significant synovitis will also be excluded.

5. Pregnant women and Lactating mothers – will be excluded

6. Patient having Rheumatoid arthritis or having Gouty arthritis will be excluded.

7. Patient having secondary osteoarthritis (except control DM and thyroid disorder) infective or inflammatory arthritis of knee joint will be excluded.

iv) CRITERIA FOR WITHDRAWAL:

1. Personal matter

2. Aggravation of complaints

3. Intercurrent illness

4. Any other difficulties

v) TYPE OF STUDY: Phase 2 Randomised parallel design study.

vi) PERIOD OF STUDY:Three month

vii) FOLLOW UP PERIOD DURING TRIAL: Fifteen days intervals.

viii) FOLLOW UP PERIOD AFTER TRIAL: One month after treatment.

ix) GROUPING OF PATIENTS: For the present clinical trial entitled “A comparative clinical study to evaluate the efficacy of Suddha Guggulu and Suddha Salai guggulu in case of janugata sandhivata (w.s.r. to knee osteoarthritis)” minimum 60 patients will selected of the age group 41-70years and divided in to two groups.

Group- A: The patients of group A will be treated with Suddha Guggulu in the doses of 500 mg. TDS with lukewarm water after meal for three months. along with 15 ml nirgundi tail for local application twice a day in the form of gentle massage.

Group-B: The patients of group B will be treated with Suddha Salai guggulu in the dose of 500 mg. TDS with lukewarm water after mealfor three months along with 15 ml. nirgundi tail for local application twice a day in the form of gentle massage.

SAMPLE SIZE: Minimum 60 patients of Janugata sandhivata (Knee osteoarthritis) from O.P.D. and I.P.D. of State Ayurvedic College and Hospital, Lucknow and referred cases of other Hospitals will be taken for trial.

TREATMENT SCHEDULE WITH DOSE AND DURATION:

The trial drugs will be given for a duration of three months as mentioned below ….

1. Suddha Guggulu :-

Dose : One vati (500 mg each), TDS

Anupan : Luke warm water after meal

Duration : Three months

2. Suddha Salai guggulu :-

Dose : One vati (500 mg each) , TDS

Anupan : Luke warm water after meal

Duration : Three months

ASSESSMENT OF RESULTS :

For the gross assessment of result obtained, the response of the treatment will be determined in terms of degree of remission of sign and symptoms as :

·        Relieved : The patients having improvement ≥ 75% symptomatically and in radiological and laboratory findings (if any).

·        Improved : The patients having improvement < 75% and > 40% symptomatically, Radiological and laboratory findings (if any).

·        Not Improved : Patients having improvement < 40% symptomatically and in Radiological and laboratory findings (if any).

·        Worsened Response :Patients having deterioration in their symptoms, and in Radiological and laboratory finding (if any).