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CTRI Number  CTRI/2021/03/031621 [Registered on: 01/03/2021] Trial Registered Prospectively
Last Modified On: 16/06/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Management of avascular necrosis of femoral head in Ayurveda  
Scientific Title of Study   A Pilot study to evaluate the efficacy of an Ayurvedic protocol in the management of"ASTHIMAJJAGATAVATA w.s.r to Avascular necrosis of femoral head" 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhawna Solanki 
Designation  PG Scholar 
Affiliation  All India Institute of Ayurveda  
Address  Room No. 725 Department of Panchkarma Academic Block All India Institute of Ayurveda Gautam Puri Sarita Vihar New Delhi 110076

South
DELHI
121102
India 
Phone  07988402663  
Fax    
Email  solankibhavnadr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prasanth Dharmarajan 
Designation  Assistant Professor 
Affiliation  All India Institute Of Ayurveda 
Address  Room No. 725 Department of Panchkarma Academic Block All India Institute of Ayurveda Gautam Puri Sarita Vihar New Delhi 110076

South
DELHI
110076
India 
Phone  9895174060  
Fax    
Email  drprasanthd@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Bhawna Solanki 
Designation  PG scholar 
Affiliation  All India Institute Of Ayurveda 
Address  Room No. 725 Department of Panchkarma Academic Block All India Institute of Ayurveda Gautam Puri Sarita Vihar New Delhi 110076

South
DELHI
121102
India 
Phone  07988402663  
Fax    
Email  solankibhavnadr@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda Sarita vihar Gautam puri New Delhi 110076 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  All India Institute of Ayurveda Gautam Puri Sarita Vihar New Delhi 110076 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Bhawna  All India Institute of Ayurveda  Room No. 725 Department of Panchkarma Academic Block All India Institute of Ayurveda Gautam Puri Sarita Vihar New Delhi 110076
South West
DELHI 
7988402663

solankibhavnadr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M95-M95||Other disorders of the musculoskeletal system and connective tissue. Ayurveda Condition: ASTHIMAJJAGATAVATA,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Udvartana Patrapinda swedana Kaishore Guggulu Dashmoola Kwatha   Procedure Udvartana ( a powder massage) with Triphala Churna 200 gms for 7 Days Patra pinda Swedana ( a sudation method with pottali) with Eranda, Nirgundi, Shigru for 7 days Koshtha Shuddhi( mild )purgation therapy with Eranda Taila 20 ml orally for 1 Day Yoga basti 1)Anuvasan Basti( therapeutic enema) Guggulutiktaka Ghrita 60ml + Sahacharadi Taila 60ml + Saindhav 5gm+ Shatapushpa 10gm For 5 days (on 1,3,5,7,8th day) Nirooha Basti( Decoction enema) Maha Manjistha + Dashamoola kwatha Ksheerapaka(240ml) + Makshika (honey)60ml + Saindhava 10gms + Guggulu Tiktak ghrita75ml + Shatpushpa Kalka 30gms For 3 Days (2, 4, 6th Day) Samshaman Aushadhi(oral Mediciene) Kaishore Guggulu 250 mg (TDS)for 30 days Maha manjishtadi Kwatha 40 ml (TDS) for 30 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Age group between 18- 50 yrs
Chronicity-1-5 yrs
Gender-both
Socioeconomic status-both
Diagnostic criteria- Diagnosed cases of Avascular Necrosis of femoral head of grade 1 and 2 with MRI findings
 
 
ExclusionCriteria 
Details  Chronicity of more than 5 yrs
Severely deformed joints.
Cardiac disease, pulmonary tuberculosis, severe lung disease, diabetes and pregnant women, exposed skin related disease
Patients unfit for Pinda svedana, Udwartan and Basti Karma.

Patients with Grade 3 and Grade 4 AVN
Fracture or dislocation induced AVN.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in pain.  1st day and 84th day 
 
Secondary Outcome  
Outcome  TimePoints 
Overall improvement in quality of life.  1st day and 84th day 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/03/2021 
Date of Study Completion (India) 27/05/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 27/05/2022 
Estimated Duration of Trial   Years="1"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

 Introduction

AVN or Osteonecrosis of the femoral head is a pathological process that results due to any injury or any occluded blood vessel nourishing the bone tissue which leads to the death of marrow and osteophyte resulting in collapse of necrotic segment of femoral head.In the early stages, there is severe pain from the dying bone. Later this leads to arthritis of the hip, causing stiffness, limitation of movement and disability of the patient in day to day routine life.In India as there is no reliable statistical data available considering the population over a billion approximately 16000 patients get affected with AVN each year. In modern medicine there is no specific treatment available except surgery. (The disease occurrence is more in women than in men with the ratio 1:8.Many surgical procedures like drilling and insertion of bone grafts, modified Whitmen and Colonna reconstructions and insertions of prosthesis are carried out. All these are cost worthy and prognosis is very poor.  It is the the most challenging condition of the present era in orthopedics.

In Ayurveda, it can be correlated with Asthi-majjagata vata due to similar signs and symptoms of Avascular Necrosis of Neck of Femur. Sign and symptoms of Avascular Necrosis are nearer to Asthivaha Srotodusti Vikara (disorders of musculoskeletal origin). Wide range of treatment modalities have been mentioned in Ayurveda particularly by the use of Panchkarma  and  natural mediciens that are effective in such manifestations.Hence this study is planned,

OBJECTIVES 

 PRIMARY: To evaluate the combined effect of Rukshana,,Patrapinda Swedana and Yoga Basti  in the  pain management and improvement in range of motion in patients with Avascular necrosis of femoral head.

 

 SECONDARY:

1.      To improve the Quality of Life in patients with Avascular necrosis of femoral head.


METHODOLOGY-

Type of Study Design- Single arm clinical open ended pilot study.

Sample size  15 

Sample Collection: - Patients attending the Panchakarma OPD & IPD of AIIA fulfilling diagnostic criteria will be recruited. 

Duration-84 days

The present dissertation entitled “A pilot study to evaluate the efficacy of  An Ayurveda Protocol in the Management of AsthimajjaGatavata W.S.R to Avascular necrosis of femoral head” is a clinical study to know effectiveness of Ayurvedic management in AVN.The present      work consists of the following 5 chapters:

 

        1.Introduction

        2. Review of Literature

a)     Conceptual Study

b)    Ayurvedic Review

c)     Modern Review

d)    Drug Review

e)     Procedure Review

      3.   Materials and method

1.     Observations and results

2.     Discussion

3.     Conclusion

 

INTRODUCTION:

 

This chapter deals with the general description of the disease Avascular necrosis of femoral head & its Ayurveda correlation disorders including incidence-prevalence and importance of Avascular mecrosis of femoral head. The   selection of protocol for the present clinical study has been briefly described in this part. Reasoning behind the selection of the therapy also has been discussed . Framework of trial is briefly discussed  in this chapter .


     OBJECTIVES OF THE STUDY:-

 

The study was planned under following objectives

 

·       PRIMARY: To assess the efficacy of Ayurveda protocol based on AsthiMajjaGataVata Chikitsa in the management of pain and  improvement in range of motion in patients of Avascular necrosis of femoral head

·       SECONDARY: To improve the Quality of Life in patients with Avascular necrosis of femoral head

 

REVIEW OF LITERATURE:

 

Ø  It deals with the historical review of AsthimajjaGatavata, etymology, definition and physiological aspects of Asthi and Majja Dhatu with Gata Vata concept. Also conceptual study on Nidana, Purvarupa, Rupa, Samprapti, Sadhyasadhyata, Chikitsa and Pathyapathya of AsthimajjaGatavata.

Ø  Conceptual study on Avascular Necrosis, Causes, its types, symptoms and treatment.

Ø  This chapter also contains the historical review, previous research works, disease review and review of related drugs.

Ø  Also the general aspects of given Panchakarma procedures such as - importance of Udvartana, Swedana, and Basti Karma, brief historical review of Udvartana Sweadana, and Basti Karma, classification with some details, indications and contraindications of all the procedures.

Ø  Drug review consists of a brief description of the drugs used in the study. The drug profile contains the features of the species, family characters, rasa paá¹…chaka and pharmacological actions etc. along with their classical respective therapeutic uses.


 

CLINICAL STUDY:

 

Materials and methods:

 

This part deals with methodology adopted for this study

1. Inclusion and exclusion criteria

2. Intervention of drug & procedure adminsteratered  like Udvartana, Patra Pinda swedana Yoga Basti,

3. Assessment of subjective and objective criteria.

 

Observations and results:


The observation made on 14 patients regarding demographic incidence of age, sex, diet etc and is presented in the form of tables and chart The results were suitably tabulated and descriptively analysed by statistics. The results thus obtained are presented in the appropriate form. The results of the therapy on Avascular Necrosis are presented with Statistical analysis of both subjective and objective criteria,  in the form of table and charts.

Effect on pain ( Satata Ruk)

Pain is a primary symptom associated with AVN of femoral head The first procedure Udvartana helped to remove the Srotorodha caused by Kapha Dosha As  well as to bring lightness in body by reducing Amavastha of Doshas. Patra Pinda Swedana helped to  reduce pain due to its Ushna property exactly opposite to Sheeta guna of Vata,  as Vata is the main cause of Shoola and also due to Anti- inflammatory & analgesic effect of Nirgundi Patra used for PPS.

 

Swedana induce local hyperthermia which improves local blood and lymphatic circulation thereby improving local tissue metabolism. It also reduce inflammation by modifying secretion of various inflammatory mediators, reflexing local musculature by physical effect of heat.

It is clear that  the given protocol  have reduced the Pain ( Satata Ruk) significantly  in the patients           of AsthimajjaGatava, Pain (Ruk) is  produced mainly by Vata Prakopa and the Basti is the best treatment for Vata. Site of vata is Pakvashaya and Basti being administered through the rectal route is the closer route of administration than oral administration .This may be the reason of improvement in Pain. Basti has procedural effect also along with the drug effect According to Ayurveda, the ingredients of Basti reach up to the small intestine and get absorbed through the gut wall, are distributed in the body and thus exert systemic effects.

.Pain reduction was the primary objective of the study, Here in this study by using of F-test it was measured that pain reduced by every single procedure starting from Rukshana to Shamana. After completion of follow up, pain gradually reduced by 40.19%.

 Effect on Range of Motion

The present study found that, after  84 days of treatment there was increase in the range of motion of  bilateral hip joint of all the patients, flexion 20.8%, extension 28.9%, abduction 31.2%, adduction 40.8%, external rotation 51.8%, internal rotation 50%,respectively of Right hip joint & in left hip joint it was 14.8% flexion, 39%  extension 18.6%  abduction, 30% adduction, 58% internal  rotation, 59.2% external rotation. Decreased Range of motion in AVN patients is due to stiffness cause by  Vata and Kapha Prakopa  due to Sheeta Guna, of vata & Srotorodha caused by  Kapha Dosha. Udvartana &  Patra Pindra swedana helped to remove the stiffness. Swedana, due to its Stambhaghna property and Patra pinda Sweda due to hyperthermia & massage together, provides muscle relaxant effect and reduces stiffness. Basti leads to Strotoshodhana resulting into free movement of Vata  This might be the reason for Improvement in Range of motion

 

Effect on  Quality of life:

The Secondary objective of the study was to improve the quality of life of patients with ONFH. The mean age of 14 patients in our study was 33.9 yrs  (range 18-50 yrs). Most patients affected were in the 3rd and 4th decade of life. The quality of life on patients with ONFH is significantly reduced because of considerable morbidity associated with the disease, especially with bilateral involvement[2]. There was significant improvement noticed after the treatment in all 9 domains of Sf 36 questainnaire  Physical functioning, Role of limitation due to physical functioning, Role of limitation due to emotional functioning, Emotional well being, Fatigue, Social Functioning, Pain, General health, Health Change which is  74.5%, 81.8%, 66.9%, 56.9%, 63.4%, 68.8%, 80.7%, 69.0%, 70.1% respectively. The maximum improvement  if found in pain & Role of limitation due to physical functioning. All the procedures given to the patients in the protocol was primarily focusing on the pain management, so it might be the reason that these two parameters were showing more improvement along with rest all other parameters





 
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