**2. Evidence-based research studies**

The research studies carried out by researchers of Ayurveda with the help of different sources of *Agnikarma* in the management of OA knee joint has been summarized with a brief methodology and results citing the references of published research studies for further details.

Pragnesh D. Pandya had conducted a study on 18 patients of *Sandhigata Vata* (osteoarthritis) of knee joint with the aim to evaluate the role of *Agnikarma* and internal Ayurveda medicine in the management of OA knee joint [42]. Selected patients were divided into 3 groups. In group A (*n* = 6), patients were treated with *Binduvata Agnikarma* by boiling *Ghrita* (clarified butter) after local anesthesia (2% lignocaine) in the respective knee joint one time. In group B (*n* = 6), patients were treated by *Vata Vidhvansadi Yoga* followed by *Shuddha Guggulu Vati* as internal medicines for 12 weeks. In group C (*n* = 6), patients were treated with both the therapies, that is, *Agnikarma* locally and drugs internally. Those patients who were in group A and B were observed with equally benefited patients who were treated locally as well as with internal medicines, that is, patients in group C, showed comparatively better results than group A and B. The study concluded that *Agnikarma* offers a better and competent solution in the management of *Sandhigata Vata* (OA of knee joint).

Dhiraj D. Chandasna had done further study on 21 patients of *Sandhigata Vata* (OA of knee joint) [43]. All 21 patients were divided in 3 groups. In group A (*n* = 7), patients were treated with *Binduvata Agnikarma* by boiling *Ghrita* (clarified butter) after local anesthesia on the affected knee joint one time. In group B (*n* = 7), patients were treated with *Vata Vidhvansadi Yoga* followed by *Shuddha Guggulu Vati* as internal medicines for one month. In group C (*n* = 7), patients were treated with both the therapies, that is, *Agnikarma* locally and drugs internally. 100% relief in all the symptoms was found in 4 patients out of 7 in group A, 1 patient out of 7 in group B, and all 7 patients in group C. Those patients who were in group C showed comparatively better relief among the 3 groups. The study concluded that *Agnikarma* is effective in the management of *Sandhigata Vata* (osteoarthritis).

Nilesh G. Jethava reported a study on 28 patients of *Janu Sandhigata Vata* to evaluate the efficacy of *Agnikarma* with *Rajata* and *Loha Shalaka* in the management of *Janu Sandhigata Vata* (OA of knee joint) [44]. A study was carried out in two groups, in which patients of group A received *Agnikarma* treatment with *Rajata Shalaka* and patients of group B received *Agnikarma* treatment with *Loha Shalaka* once a week for 4 weeks. Both groups showed statistically insignificant difference in the result. *Loha Shalaka* showed better result for pain relief compared to *Rajata Shalaka.* The study has proven the efficacy of *Agnikarma* in *Janu Sandhigata Vata* (OA of knee joint) for pain management.

Sucheta Ray conducted RCT on *Agnikarma* with two different Shalakas in OA of knee joint [45]. A total of 30 patients were divided into two groups: *Rajat Shalaka* and *Tamra Shalaka*. Assessment was done after the follow-up on 7th and 14th days. In patients treated with *Rajat Shalaka*, complete remission was seen in 3 patients (20%), remarkable improvement in 6 patients (40%), and moderate improvement in 6 patients (40%). In patients treated with *Tamra Shalaka*, complete remission was seen in 2 patients (13.33%), remarkable improvement in 4 patients (26.66%), and moderate improvement in 9 patients (60%). Results in both groups were statistically highly significant with *p* value of ≤0.0001. The study showed that *Agnikarma* with *Rajata Shalaka* was more effective than *Tamra Shalaka* in relieving the pain, tenderness, and other signs and symptoms of *Janu Sandhigata Vata* (OA of knee joint).

Aneesh Sharma carried out RCT on *Agnikarma* and *Panchatikta Guggulu* in the management of *Sandhivata* (OA of knee joint) [11]. A total 33 patients with *Janugata Sandhivata* were divided into 2 groups; in group A (*n* = 18), *Agnikarma* was done with *Panchadhatu Shalaka* once every week for one month, while in group B (*n* = 15), *Agnikarma* was done along with *Panchatikta Guggulu* given orally for one month.

*Sandhishula* (pain), *Sparshaasahyata* (tenderness), *Sandhisphutana* (crepitus), and *Sandhigraha* (stiffness) were weekly assessed by subjective gradation, and a range of movement (ROM) was recorded in research proforma. In *Sandhishula*, 86% relief was seen in group A, whereas 77.78% relief was seen in group B. *Sparshaasahyata* was reduced by 69% in group A, while 87.78% in Group B. Nearly 39% improvement was seen in *Sandhisphutana* in Group A, while 46.67% in Group B. In *Sandhigraha*, 63% relief was obtained in each of the groups. The patients got relief from the pain after first sitting of *Agnikarma* in both the groups. The relief was sustained for more than 3 months in most of the patients, as noted during follow-up. There was no significant difference in radiological findings before and after treatment in both the groups.

Mohasin Kadegaon et al. conducted a clinical study on 30 patients of *Sandhigata Vata* with special reference to *Janu Sandhi* (OA of knee joint) [46]. The aim of the study was to evaluate the efficacy of *Agnikarma* and *Svedana* in the management of OA of the knee joint. All the selected patients were equally divided into 2 groups. In group A (*n* = 15), patients were treated with *Agnikarma* in the affected knee joint in a single sitting by *Lohadhatu Shalaka*, and in group B (*n* = 15), patients were treated with *Dashamula Nadisveda* for 7 days. Follow-up was done on 7th and 14th days. *Agnikarma* with *Lohashalaka* is more effective in the management of *Vedana* and *Stambha*, whereas *Dashamula Nadisveda* is more effective in treating *Sandhisotha.* The overall result of improvement seen in group A was 74.62%, while in group B it was 70.19%. The study showed better and quick result in *Agnikarma* with *Lohashalaka* as compared to *Dashamula Nadisveda* (OA of knee joint)*.*

Parth Pandya et al. did further study on 30 patients with *Janu Sandhigata Vata* (OA of knee joint) [47]. In group A (*n* = 15), patients were treated with *Agnikarma* by *Panchadhatu Shalaka* once a week for one month. In group B (*n* = 15), patients were treated with *Agnikarma* by *Panchadhatu Shalaka* along with *Panchatikta Guggulu* orally for one month. There was not much difference in the percentage of improvement in both groups. However, the combined effect of *Agnikarma* and oral *Panchatikta Guggulu* showed better results in reference to relief in the complaints of joint pain, joint stiffness, and crepitus.

Anju Lata et al. carried out RCT on a comparative study of conductive and direct method of *Agnikarma* with *Tamra Shalaka* in *Sandhigatvata* [48]. A total of 60 patients with OA of knee joint were divided into two groups. In the conductive method (*n* = 30) and direct method (*n* = 30) of *Agnikarma* with *Tamra Shalaka* at an average temperature of 150°C and 50°C, respectively, it was found that the pain, tenderness, and swelling were significantly reduced after treatment by both methods with a *p*-value less than 0.05. But in the direct method, more effective and satisfactory result was found than in the conductive, which method might be due to a high temperature of about 150°C. The study concluded that *Agnikarma* shows good results in pain relief when the temperature of the *Shalaka* is 150°C and more in conditions like osteoarthritis of knee joint.

Ruchi Pandey carried out an RCT to evaluate the effect of *Agnikarma* along with *Panchatikta* Guggulu in the management of *Janu Sandhigata Vata* (osteoarthritis of knee joint) [49]. In group A (*n* = 21), 4 sittings of *Agnikarma* were done with *Panchadhatu Shalaka*. In group B (*n* = 20), 4 sittings of *Agnikarma* were done with *Panchadhatu Shalaka* along with *Panchatikta Guggulu* orally for one month. Significant relief was observed in both groups in all subjective parameters. Clinically and percentage wise, group B showed better results. The study concluded that *Agnikarma* alone has a definite role in reducing the knee joint pain and tenderness, but the addition of *Panchatikta Guggulu* showed convincing results in stiffness, swelling, and range of movement of knee joint. The author also demonstrated a video of *Agnikarma* for the same study [50].

Shubham Puri conducted a study on *Agnikarma* and indigenous drugs in the management of *Janu Sandhigata Vata* w.s.r. to OA of knee joint [51]. In this study, in group A, 15 patients received oral indigenous drugs, while in group B, 15 patients received *Agnikarma* with *Rajat Shalaka. Agnikarma* was done in four sittings with a weekly interval. The group of patients who received *Agnikarma* showed better results as compared with the orally treated group of patients. In terms of the two parameters of pain and range of movements, *Agnikarma*-treated patients showed very good result as compared to patients treated with oral medications. The study concluded that *Agnikarma* was found to be very effective in the management of *Janu Sandhigata Vata* (OA knee joint).

Syyed MJ carried out RCT on *Agnikarma* in 60 patients of *Janu Sandhigata Vata* w.s.r to OA of knee joint [52]. Patients were randomly allocated to receive either conservative medicine or *Agnikarma* for a period of 15 days. Clinical efficacy was evaluated on 7th and 14th days on the basis of cardinal symptoms with a visual analogue scale. Treatment with *Agnikarma* produced a significant drop in the severity of pain (*p* < 0.001). Radiological assessment, however, did not show any significant changes in both the groups.

Lobo SJ did a comparative clinical trial on 60 patients with *Janu Sandhigata Vata* (OA of knee joint) [53]. The aim of the study was to evaluate the effect of *Agnikarma* (therapeutic heat burn) by *Suvarna Shalaka* (rod made of gold) and *Panchadhatu Shalaka* (rod made up of five metals). All patients were divided into two groups. In group A (*n* = 30), patients were treated by *Agnikarma* with *Suvarna Shalaka*, and in group B (*n* = 30), patients were treated by *Agnikarma* with *Panchadhatu Shalaka* once a week for four weeks. All patients were followed up after 15th and 30th days. The statistical analysis showed that *Agnikarma* by *Suvarna Shalaka* was statistically more significant in reduction of pain, tenderness, crepitus, swelling, angle of flexion, and extension compared to *Agnikarma* by *Panchadhatu Shalaka.* Thus, the study concluded that *Suvarna Shalaka Agnikarma* is found more beneficial than *Agnikarma* using *Panchadhatu Shalaka* in prime symptoms of *Janu Sandhigata Vata* (OA of knee joint).

Raut SR conducted a case-based study on pain management by the conductive method of *Agnikarma* with *Suvarna Shalaka* in *Janu Sandhigata Vata* [54] in three sittings. On every 7th day, it was observed that the response of the patient was good to conductive *Agnikarma* therapy. The pain is reduced in VAS from 7/10 to 0/10. ROM flexion improved from 110 to 135 with no burn marks.
