| 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.
|
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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 |
|
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Source of Monetary or Material Support
|
| National Institute Of Ayurveda,Jaipur, Rajasthan, 302002 India |
|
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Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Jorawer Singh Gate, Amer Road,Jaipur(Raj.) -302002 |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee , National Institute Of Ayurveda |
Approved |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M955||Acquired deformity of pelvis. Ayurveda Condition: ASTHIGATAVATAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•रà¥à¤®/वसà¥à¤¤à¤¿à¤•रà¥à¤® | (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 |
|
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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.
|
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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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
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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. |