| CTRI Number |
CTRI/2025/02/080200 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
09/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To prove the efficacy of Guduchyadi Aasthapana Basti And Madhutailik Badti in management of Gambhir Vatarakta w.s.r. Ankylosing Spondylitis |
|
Scientific Title of Study
|
An Open Labelled Randomised Comparative Clinical Study To Evaluate The Efficacy Of Guduchiyadi Aasthapana Basti And Madhutailik Basti In Management Of Gambhir Vatarakta [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 |
Shubhi Sharma |
| Designation |
MD Panchkarma Scholar |
| Affiliation |
Institute for ayurved studies and research Shri Krishana Ayush University |
| Address |
Room no 29,1st floor,Department of Panchkarma, Institute for Ayurved Studies and Research Shri
krishana Ayush University kurukshetra Haryana 136118 India
Kurukshetra
HARYANA
136118
India |
| Phone |
8307871779 |
| Fax |
|
| Email |
DR.SS18714@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raja Singla |
| Designation |
Assistant Prof. PG Department of Panchkarma |
| Affiliation |
Institute for ayurved studies and research Shri Krishana Ayush University |
| Address |
Room no 68,1st floor,Department of Panchkarma, Institute for Ayurved Studies and Research Shri
krishana Ayush University kurukshetra Haryana 136118 India
Kurukshetra
HARYANA
136118
India |
| Phone |
9996867471 |
| Fax |
|
| Email |
singla.raja37@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shubhi Sharma |
| Designation |
MD Panchkarma Scholar |
| Affiliation |
Institute for ayurved studies and research Shri Krishana Ayush University |
| Address |
Room no 29,1st floor,DEpartment of Panchkarma,Institute for Ayurved Studies and Research Shri
krishana Ayush University kurukshetra Haryana 136118 India
Kurukshetra
HARYANA
136118
India |
| Phone |
8307871779 |
| Fax |
|
| Email |
DR.SS18714@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies and Research Shri krishana Ayush university kurukshetra Haryana
136118 india |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved Studies and Research Shri krishana Ayush University |
| Address |
Sector-8, Umri road kurukshetra 136118 Haryana India |
| 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 Shubhi Sharma |
Institute for Ayurved Studies and Research Shri krishana Ayush University |
ROOM NO 29,Department of panchkarma,Shri Krishna Ayush University Umri road sector 8
kurukshetra
Kurukshetra
HARYANA |
8307871779
DR.SS18714@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M450||Ankylosing spondylitis of multiplesites in spine. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Sushruta Chikitsha-38 , Procedure details: 16 basti of Guduchyadi aasthapana basti)
| | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Bhel vatarakta chikitsha , Procedure details: 16 kala basti of Madhutailik basti)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient who are Basti - Yogya.
2. Individuals displaying the symptoms of Ankylosing Spondylitis will be chosen as patients,
regardless of their caste, religion or occupation.
3. Individuals displaying the symptoms of Gambhir Vatarakta will be chosen as patients,
regardless of their caste, religion or occupation.
4. Patient within age group of 18 - 60 years.
5. HLA B-27 will be positive.
6. Patient who is willing and able to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Patients aged below 18 years and more than 60 yrs.
2. Patient who is contraindicated for Basti.
3. Pregnant and lactating women.
4. Patient with chronic systematic illness (Cardiac Diseases, Cirrhosis of the Liver, Diabetes,
Hypertension, Chronic Renal Disorder, Carcinoma, Endocrine Disorders).
5. Patient with Ano-rectal Diseases. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quantitative improvement in the value of HLAB-27 |
Ist- 0 Day.
IInd - After the completion of total 16 Basti. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in subjective and objective parameters.
Improvement in ESR & CRP values. |
Ist- 0 Day.
IInd - After the completion of total 16 Basti. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/03/2025 |
| 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 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
|
Ankylosing Spondylitis is characterized by chronic inflammatory arthritis predominantly affecting the sacroiliac joints and spine which can progress to bony fusion of the spine(1). Chronic back pain and progressive spinal stiffness are the most common features of the disease. Symptoms are exacerbated by inactivity and relieved by rest. Ankylosing spondylitis cannot be directly correlated with any particular disease in Ayurveda. However, on the basis of symptoms of disease, it can be correlated with Gambhir Vatarakta. To assess the effect of Guduchyadi Aasthapana Basti and Madhutailik Basti in reduction of HLAB-27 value. |