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CTRI Number  CTRI/2026/01/101930 [Registered on: 23/01/2026] Trial Registered Prospectively
Last Modified On: 22/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   "An Ayurvedic Clinical Study on the Management of Hip Bone Degeneration Using Basti Therapy with and without Leech Application."  
Scientific Title of Study   Randomized Comparative Clinical Study To Evaluate the Efficacy Of Basti With And Without Jalaukavcharana in the Management Of Asthimajjagata Vata With Special Refernce 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  DrMuskan Agarwal 
Designation  PG Scholar 
Affiliation  National Institute Of Ayurveda Jaipur 
Address  National Institute Of Ayurveda Jaipur Joravar Singh Gate Jaipur Jaipur Rajasthan 302002
Room No 114 Panchakarma Department NIA Jaipur Jaipur RAJASTHAN 302002 India
Jaipur
RAJASTHAN
184101
India 
Phone  9694746288  
Fax    
Email  muskiagarwal98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gopesh Mangal 
Designation  Professor and Head of Department 
Affiliation  National Institute Of Ayurveda Jaipur 
Address  National Institute Of Ayurveda Jaipur Joravar Singh Gate Jaipur
Room No 114 Panchakarma Department NIA Jaipur Jaipur RAJASTHAN 302002 India
Jaipur
RAJASTHAN
184101
India 
Phone  8619849011  
Fax    
Email  gmangal108@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gopesh Mangal 
Designation  Professor and Head of Department 
Affiliation  National Institute Of Ayurveda Jaipur 
Address  National Institute Of Ayurveda Jaipur Joravar Singh Gate Jaipur
Room No 114 Panchakarma Department NIA Jaipur Jaipur RAJASTHAN 302002 India
Jaipur
RAJASTHAN
184101
India 
Phone  8619849011  
Fax    
Email  gmangal108@gmail.com  
 
Source of Monetary or Material Support  
National Institute Of Ayurveda,Jorawar singh gate,Amer Road,Jaipur,302002,Rajasthan,India 
 
Primary Sponsor  
Name  NATIONAL INSTITUTE OF AYURVEDA JAIPUR 
Address  National Institute of Ayurveda Amer Road, Jaipur, Rajasthan, 302002,India 
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 Muskan Agarwal  National Institute of Ayurveda  OPD of department of Panchakarma(Room No.2)and IPD of Department of Panchakarma, male and female ward Jaipur Rajasthan
Jaipur
RAJASTHAN 
09694746288

muskiagarwal98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee National Institute Of Ayurveda Jaipur  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-jalaukAvacaraNam, जलौकावचरणम् (Procedure Reference: sushrut sutrasthan 13/19, Procedure details: 4 cycles with 2-3 Jalauka every 7th day along with Shamana period.)
2Comparator ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: charak sutrasthan 28/27, Procedure details: (Procedure Reference: CHARAK CHIKITSASTHANA 28/93, CHARAK SUTRASTHAN 28/27, Procedure details: Procedure details: Medicated enema will be administered through rectal route empty stomach.) BASTI KARMA- Panchtikta ksheer basti (total quantity about approx.575 ml before meal) & Anuvasana Basti with Ketakyadi taila (total quantity about 70ml/day after meal) Duration -16 days ) (1) Medicine Name: ketakyadi taila, Reference: sahastrayogam tail prakaranum, Route: Oral, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Duration: 30 Days)
(1) Medicine Name: ketakyadi taila, Reference: sahastrayogam taila prakaran, Route: Oral, Dosage Form: Taila, Dose: 5(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 of either gender aged between 18-60 years.
2.Patient having classical signs and symptoms of Asthimajjagata Vata (Bhedo asthi parvanum, balakshaya, Aswapna, Santataruk )
3.Patient having clinical signs and symptoms of avascular necrosis of femoral head.
4.Patients fit for Basti and Jalaukavcharana therapy.
5.Patients pre-diagnosed with Avascular necrosis of femoral head.
 
 
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   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in harris hip score  : Baseline-
Mid Treatment – (on 17th day)
Post Treatment- (on 46th day)
 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in sign and symptoms of Asthimajjagata Vata
Changes in Range of Motion

 
Continuous monitoring throughout the study
Specific assessments (on 0 Day, on 17th Day, on 46th Day)
 
 
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   Phase 2 
Date of First Enrollment (India)   01/07/2026 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 Panchtikta ksheer basti and  ketakyadi taila anuvasana basti followed by Ketakyadi taila as Shamana Aushadha and jalaukavcharana will be planned.

 
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