| CTRI Number |
CTRI/2025/04/086018 [Registered on: 30/04/2025] Trial Registered Prospectively |
| Last Modified On: |
02/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluating The Effect Of Rukshana and Vasti Therapy in the management
Of Ankylosing Spondylitis. |
|
Scientific Title of Study
|
Clinical Evaluation Of Comprehensive Ayurveda Treatment Protocol In The Management Of Ankylosing Spondylitis. |
| 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 Himanshi Choudhary |
| Designation |
MD Scholar |
| Affiliation |
Dr BRKR Govt Ayurvedic Medical College |
| Address |
Dr BRKR Govt Ayurvedic Medical College Opposite ESI Hospital Towards SR Nagar AG Colony Rd Sultan Nagar Erragada Hyderabad Telangana 500018
Hyderabad
TELANGANA
500018
India |
| Phone |
9494517741 |
| Fax |
|
| Email |
himanshi7741@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrPraveen Kumar Madikonda |
| Designation |
PG Reader |
| Affiliation |
Dr BRKR Govt Ayurvedic Medical College |
| Address |
Dr BRKR Govt Ayurvedic Medical College Opposite ESI Hospital Towards SR Nagar AG Colony Rd Sultan Nagar Erragada Hyderabad Telangana 500018
Hyderabad
TELANGANA
500018
India |
| Phone |
9849271601 |
| Fax |
|
| Email |
pkmadikonda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrPraveen Kumar Madikonda |
| Designation |
PG Reader |
| Affiliation |
Dr BRKR Govt Ayurvedic Medical College |
| Address |
Dr BRKR Govt Ayurvedic Medical College Opposite ESI Hospital Towards SR Nagar AG Colony Rd Sultan Nagar Erragada Hyderabad Telangana 500018
Hyderabad
TELANGANA
500018
India |
| Phone |
9849271601 |
| Fax |
|
| Email |
pkmadikonda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. BRKR Govt. Ayurvedic medical college and hospital, Erragadda, Hyderabad, Telangana, 500018 |
|
|
Primary Sponsor
|
| Name |
Dr.BRKR Govt Ayurvedic Medical Collegee |
| Address |
Dr.BRKR Govt Ayurvedic Medical College Opposite ESI Hospital Towards SR Nagar AG Colony Road Sultan Nagar Erragada Hyderabad Telangana 500018 |
| Type of Sponsor |
Government medical college |
|
|
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 Himanshi Choudhary |
Dr. BRKR Govt. Ayurvedic medical college and hospital |
Room no 5, Department of Panchakarma, Erragadda, Hyderabad, Telangana, 500018
Hyderabad
TELANGANA |
9494517741
himanshi7741@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OF DR BRKR GOVT AYURVEDA COLLEGE HYDERABAD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M459||Ankylosing spondylitis of unspecified sites in spine. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Ruksha Karma | (Procedure Reference: Chakradatta, Procedure details: Ruksha Pinda Sweda with Kolakulathadi Churna ,Yava Churna ,Kulatha Churna and Mrdu Virechana with Gandharvahastadi Taila for 7 days)
| | 2 | Intervention Arm | Procedure | - | Kala Vasti | (Procedure Reference: Chakradatta, Procedure details: Anuvasana Vasti with Brhat Saindhavadi Taila,Gomutra Vaitarana Vasti for 16 Days)
| | 3 | Intervention Arm | Procedure | - | Meru Vasti | (Procedure Reference: Chakradatta, Procedure details: Meru Vasti with Kottamchukkadi Taila for 10 Days)
| | 4 | Intervention Arm | Procedure | - | Dwitiya Baladi Yapana Vasti | (Procedure Reference: Charaka Siddhi 12/6, Procedure details: Dwitiya Baladi Yapana Vasti for 10 Days)
| | 5 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Trayodashanga Guggulu, Reference: Bhaisajya Ratnavali Vatavyadhi adhikar, Route: Oral, Dosage Form: Guggulu , Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Rasna Saptaka Qwath, Reference: Chakradatta Amavatadhikar, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Sunthi churna ), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient diagnosed with Ankylosing spondylitis based on clinical and radiological criteria.
2.Age between 18-65 yrs.
3.Willingness to undergo Ayurvedic Panchakarma therapy.
4.Willingness to provide informed consent.
5.Patient eligible for proposed treatment protocol i.e.Ruksha Pinda Sweda,Virechana,Vasti |
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating mother.
2. Patient with severe comorbidities such as Uncontrolled Diabetes , Hypertesion or cardiac conditions.
3. History of aliergic reactions to components of Panchakarma therapy.
4. Patient undergoing immunosuppressive therapy or recent surgery.
5. Complications of Ankylosing Spondylitis with Extra Articular Manifestations.
6. Patient diagnosed with other joint disorders. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Reduction in Low back pain
2.Reduction of Inflammation
3.Improvement of Subjective parameters
4.Total improvement in quality of Life |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Improving quality of life
2. Decreasing disease progression in Ankylosing Spondylitis patients. |
6 months |
|
|
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)
|
12/05/2025 |
| 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="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
|
This is a Clinical Study to Evaluate the Comprehensive Ayurvedic treatment protocol for the management of Ankylosing Spondylitis through Rukshan Karma and special Vasti like Dwitiya Baladi Yapana Vasti. Follow up for 43 days .Assessment will be done on Comparison of Subjective and Objective symptom score index before and after treatment ,which will be subjected for statistical analysis by using Paired Student "T" test |