CTRI/2025/09/094956 [Registered on: 17/09/2025] Trial Registered Prospectively
Last Modified On:
16/09/2025
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Single Arm Study
Public Title of Study
A Clinical Study to determine the effect of an Ayurvedic treatment module on the basis of prakriti of avascular necrosis patients.
Scientific Title of Study
A Single-Arm Clinical Study To Evaluate The Efficacy Of Ayurveda Treatment Module On The Basis Of Prakriti In The Management Of Asthimajjagata Vata (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
Dr Vikas Kumar Gothwal
Designation
PG SCHOLAR
Affiliation
All India Institute of Ayurveda
Address
OPD No.6, Dept. of panchakarma, Ground floor, Hospital Block, All India Institute of Ayurveda Gautampuri, Sarita Vihar, New Delhi 110076
South West DELHI 110076 India
Phone
8595248918
Fax
Email
vikasgothwal786@gmail.com
Details of Contact Person Scientific Query
Name
Dr. Prasanth Dharmarajan
Designation
Associate Professor
Affiliation
All India Institute of Ayurveda
Address
Room No. 725, Department of Panchakarma Academic Block, All India Institute of Ayurveda Gautampuri, Sarita Vihar, New Delhi 110076 DELHI 110076 India
South West DELHI 110076 India
Phone
9895174060
Fax
Email
drprasanthd@gmail.com
Details of Contact Person Public Query
Name
Dr Vikas Kumar Gothwal
Designation
PG SCHOLAR
Affiliation
All India Institute of Ayurveda
Address
OPD No.6, Ground floor, Hospital Block, All India Institute of Ayurveda Gautampuri, Sarita Vihar, New Delhi 110076 New Delhi DELHI 110076 India
South West DELHI 110086 India
Phone
8595248918
Fax
Email
vikasgothwal786@gmail.com
Source of Monetary or Material Support
ALL INDIA INSTITUTE OF AYURVEDA
Mathura Rd, Gautampuri Awas Sarita Vihar New Delhi - 110076 , INDIA
Primary Sponsor
Name
All India Institute of Ayurveda
Address
Mathura Road,Gautampuri Awas, Sarita Vihar, New Delhi, Delhi 110076
Type of Sponsor
Government medical college
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 Vikas Kumar Gothwal
All India Institute of Ayurveda
OPD 6 Panchakarma,Ground floor, Hospital block All India Institute of ayurveda Gautampuri, Sarita Vihar, New Delhi 110076
South West DELHI
8595248918
vikasgothwal786@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Division of Translational Research & Biostatistics
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition:M870||Idiopathic aseptic necrosis of bone. Ayurveda Condition: MAJJAGATAVATAH,
Intervention / Comparator Agent
sno
Intervention/Comparator
Type
Drug-Type
Procedure Name
Details
1
Intervention Arm
Procedure
-
Deepana -Pachana
(Procedure Reference: sharangdhar samhita / purva khand (4/1-2), Procedure details: medicine will be given orally two times empty stomach for 5 days) (1) Medicine Name: Rasna/ Guduchi/Shunthi churna, Reference: bhawprakash haritkyadi varg (143-144)/ (41-45), Guduchyadi varg (8-9), Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Duration: 5 Days
2
Intervention Arm
Procedure
-
snehapAna-karma, स्नेहपान-कर्म
(Procedure Reference: charak siddhi 1/7, Procedure details: Giving medicated ghrita morning an empty stomach once from 5-7 days , start from 30 ml first day then increase according to snigdha lakshan ) (1) Medicine Name: Panchatiktak Guggulu ghrita, Reference: Ashtang hridya chikitsa sthan ( 21/58-61), Route: Oral, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Duration: 7 Days
3
Intervention Arm
Procedure
-
Virechana
(Procedure Reference: Sharabgdhar uttarsthan (4/13-14), Procedure details: medicine will be orally given morning an empty stomach for 1 day ) (1) Medicine Name: Trivritta Avaleha, Reference: Ashtang hridya kalpsthan (2/9), Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 60(g), Frequency: od, Duration: 1 Days
4
Intervention Arm
Procedure
-
Kaala basti - Anuvasana-basti अनुवासन-बस्तिः
(Procedure Reference: Ashtang hridaya Sutrasthan , Procedure details: Basti/Enema will be given after lunch for 10 days as per the kaala basti schedule ) (1) Medicine Name: Bala Taila/ Ksheerabala Taila / Sahacharadi Taila , Reference: ashtang hridya chikitsa (21/ 73-81) (21/67-69),/ Sahastra yogam/, Route: Rectal, Dosage Form: Taila, Dose: 120(ml), Frequency: od, Duration: 10 Days
5
Intervention Arm
Procedure
-
Kaala basti- Nirooha basti
(Procedure Reference: ashtang hridya sutra sthan (19/1), Procedure details: Basti/Enema will be given before food as per the kaala basti schedule for 6 days. ) (1) Medicine Name: Manjishthadi kwath/Manjishthadi ksheera /Manjishthadi kshaar , Reference: sharangdhar samhita (139-144), Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 300(ml), Frequency: od, Duration: 6 Days
6
Intervention Arm
Procedure
-
patrapind swedana
(Procedure Reference: charak samhita sutrasthan, Procedure details: Swedana will be done with swag(potali) of different leaves, lemon, garlic, and coconut Powder, haldi, methi for 15 days with kaala basti) (1) Medicine Name: Nirgundi/ ksheerbala/ sahacharadi Taila, Reference: bhaisajya Ratnawali (44/75), Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 15 Days
7
Intervention Arm
Drug
Classical
(1) Medicine Name: Trayodasanga guggulu/Kaishore guggulu/Lakshadi gugguluore, Reference: bhaisajya ratnawali Vatavyadhiadhikara (89-92)/sharangdhar samhita (70-81)/bhaisajya ratnawali (4/20-21), Route: Oral, Dosage Form: Guggulu , Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: Medicine(guggulu) will be given as per the prakriti of the Patient.
8
Intervention Arm
Drug
Classical
(1) Medicine Name: Dashmoola Kwath/Brihat manjishthadi kwath/ Sahacharadi Kwath, Reference: bhawprakash guduchyadi varg (49)/Sharangdhara samhita (139-144) / Ashtanghridaya chikitsa sthan (21/56), Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: Kwath will be given according to prakriti of Patients
9
Intervention Arm
Drug
Classical
(1) Medicine Name: Panchatiktaka Guggulu Ghrita, Reference: Ashtanga hridaya chikitsa sthan (21/58-61), Route: Oral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: warm water), Additional Information: Ghrita will be given with lukewarm water
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Patients who are fit to undergo Panchkarma procedures as Snehpana, Virechana & Basti Karma.
2. Age between 18 to 65 years.
3. All cases of AVN of stage I to stage IV
according to FICAT and ARLET classification would be considered.
4. Chronicity up to 5 yrs
5. Confirmed diagnosis of Avascular Necrosis of the femoral head with MRI Findings.
6. Both genders, male and female, will be considered for the Study
ExclusionCriteria
Details
1. Known cases of uncontrolled diabetes and hypertension, Tuberculosis, or severe illness
2. Pregnant or lactating mother.
3. Patients unfit for Snehpaan, Swedan, Virechana, and Basti Karma.
4. Psychiatric or cognitive impairment.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Reduction In Pain (VAS Score)
Increase in Range of movement
at baseline, after 4 week, after 8 week, after 12 week.
Secondary Outcome
Outcome
TimePoints
Changes in serum level of RANKL BIOMARKER &
Improvement in Degenerative changes in MRI Findings.
Overall improvement in quality of life.
at baseline & after 12 weeks
Target Sample Size
Total Sample Size="63" Sample Size from India="63" 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/ Phase 3
Date of First Enrollment (India)
01/03/2026
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="0" Days="0"
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
In this study, a clinical
trial is conducted to evaluate the efficacy of the Ayurveda treatment module on
the basis of prakriti in the management of Asthi-majjagata Vata (Avascular
Necrosis ), which has been practiced before in a previous study conducted on
the Panchakarma department of the All India Institute of Ayurveda. This
treatment module will be used to manage Asthi-majjagata Vata patients based on
their prakriti (Vata, Pitta, and Kapha ). 63 is the sample size, and the
treatment period is 96 days, including 48 days of follow-up.
Participants from AIIA’s Panchakarma OPD and IPD who
fulfill the diagnostic criteria will be recruited. Ayurveda treatment module
followed by Deepana-pachan with Rasna churna in Vata prakriti, Guduchi Churna
in Pitta Prakriti, Shunthi Churna in Kapha Prakriti, Sarvang abhyanga with bala
taila in Vata Prakriti, with Ksheera bala taila in Pitta Prakriti, with Brihat
Saindhav taila in Kapha Prakriti. Sarvang Bashpa Swedana with Dashmoola Kashaya.
Snehpana with Panchatikta guggulu gahrita. Virechana with Trivritta Avaleha and erand
tail, with Trivritta Avaleha and Ksheera, with Trivritta Avaleha and Triphla Kwath.
Basti in Vata Prakriti manjishthadi
nirooha basti and bala tail anuvasana basti, in Pitta Prakriti manjishthadi
Ksheera basti and Ksheera bala tail anuvasan basti, and in Kapha Prakriti manjishthadi
Kshaar basti and Sahacharadi taila anuvasan basti. Patra Pinda swedana with
nirgundi taila in Vata prakriti, with Ksheerabala taila in Pitta Prakriti, with
Sahacharadi Taila in Kapha Prakriti, and Shaman chikitsa with trayodashanga
guggulu, Panchatikta guggulu gahrita, and dashmoola Kwath in Vata Prakriti, with
Kaishore guggulu, Brihat manjishthadi kwath, and Panchatikta guggulu gahrita in
Pitta Prakriti, with lakshadi guggulu, Sahacharadi Kwath, and Panchatikta
guggulu gahrita in Kapha Prakriti of participants.
And
the efficacy of the treatment will be assessed by the parameters VAS Scale,
Oxford Hip Score, Harris Hip Score, and SF-12 after Deepana-pachana, after
basti, after shaman chikitsa, and last after follow-up. An ELISA Test for
assessing RANKL Biomarker will be done before and after treatment. An MRI will
be performed after treatment to assess any radiological changes before and
after treatment.