management of avascular necrosis through ayurveda

Phase 2/3

Not yet recruiting

Conditions: Osteonecrosis, unspecified. Ayurveda Condition: asthimajagata vata, (2) ICD-10 Condition: M879||Osteonecrosis, unspecified. Ayurveda Condition: ASTHIGATAVATAH,

Registration Number: CTRI/2023/02/049907

Lead Sponsor: All India Institute of Ayurveda

Brief Summary: Avascular necrosis (AVN) is defined as cellular death of bone components due to interruption of the blood supply; the bone structures then collapse, resulting in pain, loss of joint function and long-term joint damage. Avascular necrosis of femoral head in the North Indian people is a disease of young individuals with male predominance. Steroid intake is most commonly observed in these patients followed by idiopathic, chronic alcohol consumption, and trauma Studies have attributed the disease process to the combined effect of genetic predisposition, metabolic factors and local factors affecting blood supply such as vascular damage, increased interosseous pressure and mechanical stress. This results in bone ischaemia.

Treatment modalities such as Deepana-Pachana, Snehpana, Virechana Karma, Patra pinda swedana & Basti karma Are Effective in the management of Asthimajjagata Vata.

Here in this study an attempt is made to find out the efficacy of customized treatment protocol as explain in Samhitas

OBJECTIVES OF THE RESEARCH PROJECT:

PRIMARY: 1) To determine the efficacy of Customized Ayurveda Treatment Module when given for a period of 63 days for reducing pain in Asthi-Majjagata Vata(Avascular necrosis of femoral Head) patients of 16-65yrs of age.

SECONDARY: 1) Subgroup Analysis would be Done Based on Prakriti. 2) To improve the range of motion in patients of Asthi-Majjagata Vata(Avascular necrosis of femoral head). 3) To Determine the change in Quality of Life in patients with Avascular necrosis of femoral head.

Study Type: Interventional Sub Type: Exploratory Timing: Prospective Masking: Open Label Grouping: Triple Arm Interventional Method: Parallel Study Site: Patients attending the Panchakarma OPD & IPD of AIIA fulfilling diagnostic criteria will be recruited

Total duration of Study- 63 days

Total duration of Procedure-33 days

Shamana aushadhi- 15 days

Follow up duration- 15 days

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: Not specified

Target Recruitment: 54

Inclusion Criteria

1.Patients who are fit to undergo Snehpana, Virechana & Basti Karma 2.Chronicity: Upto 5 years.
3.Age between 16yrs to 65yrs.
4.Gender: Irrespectively both genders will be considered for the study 5.Diagnosed cases of Avascular necrosis of femoral head with MRI findings.
6.Socio-economic status: All.

Exclusion Criteria

Known cases of uncontrolled Diabetes, Pulmonary tuberculosis other systemic illnesses and pregnant women.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in pain.	(Day-0)(Day-33)(Day-48)(Day-63)

Secondary Outcome Measures

Name	Time	Method
Increase in Range of Motion	To determine change in Quality of life

Trial Locations

Locations (1): All India Institute of Ayurveda
🇮🇳
Delhi, DELHI, India
All India Institute of Ayurveda
🇮🇳Delhi, DELHI, India
Dr Sagar Vijay Therokar
Principal investigator
8408865119
therokarsagar@gmail.com