An open label clinical trial to evaluate the efficacy of Basti along with Nitamba Basti followed by Kushmanda Ghrita in the management of Asthimajjagata Vata with special reference to Avascular Necrosis of Femoral Head

As bone is a living structure that needs blood, an interruption in the blood supply causes bone to die. This disorder is known as avascular necrosis (AVN), also known as osteonecrosis, bone infraction, aseptic necrosis, or ischemic bone necrosis. This process eventually leads to the bone collapsing if it is not prevented. Osseous cell death brought on by vascular impairment is what is known as avascular necrosis. According to estimates, 20000 to 30000 new cases of osteonecrosis are detected each year, making up 10% of the 250000 total hip arthroplasties (THA) performed in the United States each year.

Small bones can also be affected by AVN, which typically affects the epiphysis (end portion of a long bone), such as the femoral and humeral heads and the femoral condyles. In clinical practice, the hip is where AVN is most frequently found. The head of the femur, neck of the talus, and waist of the scaphoid are the three traditional sites. Avascular necrosis of the femoral head (AVNFH) is an evolving, complex, and difficult clinical issue that is on the rise.This condition most frequently affects the femoral head. At the time of diagnosis, patients  are often in their third, fourth, or fifth decade of life. Males are more likely to this illness than women, with a sex ratio of around 4.

In Ayurveda, there is no single disease which can be directly compared with AVN, but according to symptoms it comes nearly to Asthimajjagata Vata which manifesting symptoms like Bhedo Asthi Parvanam (breaking type of pain in bones and joints), Sandhi Shula (joint pain), Mamsakshaya (muscular wasting), Balakshaya (weakness), Aswapna (disturbed sleep), Santataruk (continuous pain).

Many people with avascular necrosis might not have symptoms in the early stages. As the condition increases, the injured joint may become painful when stressed. Localized, mild, intense, and onset gradually are all possible characteristics of pain. Pain may only be felt in the groin, thigh, or buttock if AVN solely affects the hip. The most common places where pain is localized are the anterior hip and lower pelvis. An acute onset is possible for acute infarct phenomena, which resembles an acute injury. The gait will change if range of motion is reduced.

The precise incidence and prevalence rates of avascular necrosis are unknown in the majority of nations. As was already indicated, 20000 to 30000 new cases of osteonecrosis are detected each year, which accounts for 10% of the 250000 total hip arthroplasties (THA) performed each year in the United States. "A Japanese study estimated that between 2,500 and 3,300 cases of AVN of the hip occur annually; of these, 34.7% were caused by corticosteroid abuse, 21.8% by alcohol abuse, and 37.1% by idiopathic (unknown) mechanisms. However, in India, there are about 16,000 new cases of avascular necrosis discovered each year, which will eventually necessitate total hip replacement surgery. Patients with avascular necrosis often range in age from 32 to 40.

Keeping all these facts in mind, an open label clinical trial of  Niruha Basti with Vishwadidwadashanga Kwath along with Nitamba Basti with Bala Tailafollowed by Kushmanda Ghritaas Shamana Aushadha will be planned.

AIM:

To determine the standard treatment for Asthimajjagata Vata (Avascular Necrosis of Femoral Head)

OBJECTIVE:

To evaluate the efficacy of Basti along with Nitamba Basti followed by Kushmanda ghrita in the management of Asthimajjagata Vata (Avascular Necrosis of Femoral Head).

RESEARCH QUESTION:

Is there any efficacy of Basti and Nitamba Basti followed by Kushmanda ghrita in the management of Asthimajjagata Vata w.s.r. to Avascular Necrosis of Femoral Head?

HYPOTHESIS:

Null Hypothesis [H0]: There is no efficacy of Basti and Nitamba Basti followed by Kushmanda ghrita in the management of Asthimajjagata Vata w.s.r. to Avascular Necrosis of Femoral Head.

Alternative Hypothesis [HA]: There is significant efficacy of Basti and Nitamba Basti followed by Kushmanda ghritain the management of Asthimajjagata Vata w.s.r. to Avascular Necrosis of Femoral Head.