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CTRI Number  CTRI/2024/07/070233 [Registered on: 09/07/2024] Trial Registered Prospectively
Last Modified On: 26/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   To evaluate the efficacy of medicated enema therapy and external oleation therapy followed by oral medication in the management of hip joint pain.  
Scientific Title of Study   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 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Annu Kaushik 
Designation  MD Scholar 
Affiliation  National Institute Of Ayurveda 
Address  Room no 114, Panchkarma Department, National Institute Of Ayurveda, Jorawer Singh Gate, Amer Road, Jaipur
Madhav Vilas Palace,Jorawer Singh Gate, Amer Road,Jaipur
Jaipur
RAJASTHAN
302002
India 
Phone  7976766468  
Fax    
Email  kaushikannu07@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gopesh Magal 
Designation  Professor & HOD 
Affiliation  national institute of ayurveda 
Address  room no 114, PanchkarmaDepartment, National Institute of Ayurveda, Jorawer Singh Gate, Amer Road, Jaipur
madhav vilas, palace,jorawer singh gate, amer road,jaipur
Rajsamand
RAJASTHAN
302002
India 
Phone  8619849011  
Fax    
Email  gopesh.pk@nia.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr Gopesh Magal 
Designation  Professor & HOD 
Affiliation  national institute of ayurveda 
Address  room no 114, PanchkarmaDepartment, National Institute of Ayurveda, Jorawer Singh Gate, Amer Road, Jaipur
madhav vilas, palace,jorawer singh gate, amer road,jaipur
Rajsamand
RAJASTHAN
302002
India 
Phone  8619849011  
Fax    
Email  gopesh.pk@nia.edu.in  
 
Source of Monetary or Material Support  
National Institute Of Ayurveda,Jaipur, Rajasthan, 302002 India 
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  Jorawer Singh Gate, Amer Road,Jaipur(Raj.) -302002 
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 
Dr Gopsh Mangal  National Institute Of Ayurveda  Room no 111, Department Of Panchkarma, Madhav Villas Palace ,Jorawer Singh Gate, Amer Road, Jaipur,Rajasthan 302002, India
Jaipur
RAJASTHAN 
8619849011

gopesh.pk@nia.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee , National Institute Of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M955||Acquired deformity of pelvis. Ayurveda Condition: ASTHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: charak samhita sutrasthan 28/27 , charak samhita chikitsa sthana 28/93, Procedure details: BASTI KARMA- Niruha Basti with Vishwadidwadashanga Kwath (total quantity about approx.575 ml before meal) & Anuvasana Basti with Bala Taila (total quantity about 70ml/day after meal) Poorva Karma-Nitamba Basti with Bala Taila )
(1) Medicine Name: Kushmanda Ghrita, Reference: Vaidya saar sangraha,English translation by M.S.Krishnamurthy in Ashtama Prakarana Verse 223-230, page-256,, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Duration: 30 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient having classical signs and symptoms of Asthimajaagata Vata.
2. Patient having signs and symptoms of avascular necrosis of femoral head
3. Patients fit for Basti therapy
4. Age- 18-60 years
 
 
ExclusionCriteria 
Details  1. Patients unfit for Basti therapy
2. Patients known case of Sickle cell anaemia and thalassemia, uncontrolled Hypertension and any active and serious systemic diseases.
3. Pregnant& lactating women.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in Harris Hip Score  61st day from baseline  
 
Secondary Outcome  
Outcome  TimePoints 
Changes in sign and symptoms of Asthimajjagata Vata
Changes in Range of Motion
Changes in walking time
Changes in quality of life
 
61st day from baseline  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="29" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

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 Taila followed by Kushmanda Ghrita as 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 ghrita in the management of Asthimajjagata Vata w.s.r. to Avascular Necrosis of Femoral Head.

 
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