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

Response - NO

Panchakarma is the specialized branch of Ayurveda which has got the importance in its own special way in preventive as well as curative aspects of the diseases Even though Panchakarma includes the mainstream procedures like Vamana, Virechana, Basti, Nasya and Raktamokshana, The Upakrama like Snehana and Swedana has also got its impact very strongly in treating the diseases. As said in treatises Swedana is considered one of the important aspects in Shadvidha Upakrama. As pradhana Karma numerous varieties of Swedana can be adopted according to the disease condition. Among them Upanaha Swedana is the variety mentioned by our Acharyas which is mainly indicated in Vataja disorders. Based on the application of Upanaha it can be divided into 3types: Acharya Dalhana stated that there are three types of Upanaha:  1.Pradeha Upanaha (a thick paste of medicament is applied to the affected part). 2.Sankar Upanaha (the paste is made into a bolus and wrapped in a cloth). 3.Bandhan Upanaha (the medicaments are used on the affected part and then firmly tied with a Thin piece of cloth or leaves with Vatahara properties) frequently we practiced Bandhana Upanaha in day to day life.Among 80 Vatavyadhi Sandhigatavata is one among them.  Acharya Charaka defined it as a disease with the symptoms of Shoola, Shotha, Vata poornadritisparsha, Prasarana akunchana janya vedana. In chikitsa sutra of Sandhigatavata Snehana, Upanaha, Agni karma, Bandhana is mentioned.  A study on Upanaha karma in the management of janusandhigatavata where the researcher studies Vachadi and Kolakulathadi Upanaha and found statistically significant results.  In Practicing classical way of Upanaha we find many drawbacks so to overcome these problems we can modify the way of application of Upanaha karma where patient himself/herself can apply the Upanaha and may get good results. Based on signs &symptoms janusandhigatavata can be corelated with Osteo-arthritis. According to epidemiology, the prevalence of OA in India is 22-39%. The incidence of the disease increase with the age the prevalence is more in females (25%) when compared to the males (16%). Almost all persons by age 40 have some pathological change in weight bearing joint. In the management of OA in contempory science or modern science a number of analgesics and anti-inflammatory drugs are available for its betterment. However, a permanent relief is not provided by any of these and the same is still under research works. Even the surgical treatment does not provide complete relief. However prolonged used of NSAID leads to increased risk of chronic diseases. Due to the increased awareness of the side effects of NSAIDS and analgesics, use of natural remedy, especially topical applications are explored due to their relative safety. Topical agents in the form of creams, ointments, gels, lotions,solutions, pastes and sprays are widely used in practice since many years due to their instant action. These reduces the local inflammation and also acts as topical analgesic. 

Need of study:

 Upanahaswedana is one among the modality of Swedana. Which is mentioned in janusandhigatavata5 . where we applied medicament externally for certain amount of time. We applied warmed thick paste on the affected part. Likewise, in modern science topical agents corelated with Upanaha. While appreciating all the clinical benefits of Upanaha, the difficulties in applying these therapeutic procedures are several. It is time consuming, there is need of man power, Preparing the medicinal mixture separately for each application hampers the patient compliance in the procedure. The prepared medicine can vary in consistency each time and lead to difficulty in application. To overcome these problemes, we can modify the way of application of Upanaha where patient can himself apply the Upanaha. It becomes important to develop an innovative form of this procedure that minimizes these challenges and maximize its potential. Modified Upanaha is a useful advancement in today’s busy life. Recent studies have demonstrated that local inflammation plays a critical role in the development and progression of OA. Topical application of an innovative Upanaha may be able to reduce these symptoms in knee OA.

Research Question:

 Whether modified Upanaha or classical Upanaha with Kolakulatthadi Choorna is effective in the pain management of Janusandhigatavata? 

Aim:

 

To compare the efficacy of Modified Upanaha and Classical Upanaha with Kolakulathadi choorna in the pain management of janusandhigatavata.

 

Objectives:

ʉۢ To develop a Modified Upanaha.

 â€¢ To prepare SOP of Modified Upanaha. 

• To study the efficacy of Kolakulathadi modified Upanaha in the pain management of janusandhigatavata. 

• To compare the efficacy of modified Upanaha and classical Upanaha with Kolakulathadi Choorna in the pain management of janusandhigatavata.

Materials and methods: 

Duration of study:18 months

Study design:Randomized comparative clinical study.

Sources of data

 

(a) Literary source: All the available literature regarding janusandhigatavata, Kolakulatthadi Choorna, Upanaha Swedana in Brihattrayi and Laghutrayi, other ayurvedic texts and modern review will be taken from articles, journals, research papers and subject related information from internet. 

(b) Pharmaceutical source: All the required drugs will be well identified and collected from local vendors and medicine required for treatment will be prepared in GMP Certified Pharmacy of Parul Institute of Ayurved, Modified Upanaha will be prepared at Parul Ayurved Hospital as per proper SOPs. 

(c) Clinical source: Patients diagnosed to be suffering with Janusandhigatavata and indicated for Swedana will be randomly selected for the study from OPD and IPD of Parul Ayurved Hospital and Khemdas Ayurved Hospital.

Treatment group:

Group A: Modified Upanaha with Kolakulatthadi Choorna– 20 patients

 Group B: classical Upanaha with Kolakulatthadi Choorna– 20 patients.

Duration of treatment: 14 days (7days Upanaha treatment then follow up on 14 th day of treatment

Diagnostic criteria:

 

A The diagnosis will be based on these clinical features; 

1. Janu Sandhi Shoola (pain) 

2. Janu Sandhi Shotha (swelling) 

3. Janu Sandhi Sphutana (crepitus) 

4.Janu sandhi graha (stiffness) 

5. Prasarana akunchana janya vedana (pain during flexion and extension) B Radiological findings (X ray of affected knee joint OA of grade1 and grade 2)

Assessment criteria:

 

 i) Subjective criteria:

Objective criteria :

1.VAS scale

2.WOMAC INDEX (MODIFIED - CRD PUNE VERSION)

3.Range of Movement measured with the help of Goniometer

Intervention:

40 patients of janusandhigatavata will be randomly divided into 2 groups: 

 Group A: Modified Upanaha with Kolakulatthadi Choorna– 20 patients Each patient will be subjected to modified Upanaha with Kolakulatthadi Choorna on Janu Pradesh. 

 Duration: Up to 6 hours per day for 7 days 

 Group B: classical Upanaha with Kolakulatthadi Choorna– 20 patients. Each patient will be subjected to classical Upanaha with Kolakulatthadi Choorna on Janu Pradesh 

 Duration: Up to 6 hours per day for 7 day

 

The effect of the upanaha(panchakarma therapy)will be assessed based on the following crieteria:

1. Sheeta Uparama (Relief of coldness) 

2. Shoola Uparama (Relief of pain) 

3. Stambha Nigraha (Relief of stiffness) 

4. Gaurava Nigraha (Relief of heaviness) 

5. Mardava (Softness of the body) 

6. Sweda (Adequate sweating) 

7. Vyadhihani (Remission of disease)