| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M955||Acquired deformity of pelvis. Ayurveda Condition: ASTHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | jalaukAvacaraNam, जलौकावचरणम् | (Procedure Reference: sushrut sutrasthan 13/19, Procedure details: 4 cycles with 2-3 Jalauka every 7th day along with Shamana period.)
| | 2 | Comparator Arm | Procedure | - | 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. |