| CTRI Number |
CTRI/2025/04/085512 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Agnikarma and Katibasthi with Devadaru Baladi Taila in the Management of lumbar spondylosis |
|
Scientific Title of Study
|
Efficacy of Agnikarma and Katibasthi with Devadaru Baladi Taila in the Management of Katisandhigata Vata (lumbar spondylosis) An Open Labelled Randomised Comparative Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KEERTHANA VP |
| Designation |
P.G. SCHOLAR |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar |
| Address |
Department of Shalya Tantra Institute of Teaching and Research in Ayurveda Jamnagar
GUJARAT
Jamnagar
GUJARAT
361008
India |
| Phone |
7902583648 |
| Fax |
|
| Email |
keerthana98vp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr T S Dudhamal |
| Designation |
H.O.D and Professor |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar |
| Address |
Department of Shalya Tantra Institute of Teaching and Research in Ayurveda Jamnagar
GUJARAT
Jamnagar
GUJARAT
361008
India |
| Phone |
9428671939 |
| Fax |
|
| Email |
drtsdudhamal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr T S Dudhamal |
| Designation |
H.O.D and Professor |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar |
| Address |
Department of Shalya Tantra Institute of Teaching and Research in Ayurveda Jamnagar
GUJARAT
Jamnagar
GUJARAT
361008
India |
| Phone |
9428671939 |
| Fax |
|
| Email |
drtsdudhamal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda Jamnagar Gujarat 361008 |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda,Jamnagar |
| Address |
Institute of Teaching and Research in Ayurveda Jamnagar 361008 |
| 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 Keerthana VP |
Institute of Teaching and Research in Ayurveda, Jamnagar |
Shalyatantra Department OPD no D19 Room no 104 ASTHISANDHAN Institute of Teaching and Research in Ayurveda jamnagar Gujarat 361008
Jamnagar
GUJARAT |
7902583648
keerthana98vp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Institute of Teaching and Research in Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M478||Other spondylosis. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | kaTibastiH, कटिबस्तिः | (Procedure Reference: AIIA/PANCHAKARMA/SOPMANUAL/01, Procedure details: Katibasthi is a procedure in which comfortably warm medicated oil 250ml (40-45 degree Celsius) kept on the lumbar area L2-L5 for 15-20 minutes of time with the help of cap like hollow structure.The oil should be changed after 4 days. The procedure should be carried out for continous 15 days with followup.))
(1) Medicine Name: Devadaru Baladi Taila, Reference: Sahasrayogam Sujanapriya vyakhyan,Taila prakarana 41 Tailayogaa, Route: Topical, Dosage Form: Taila, Dose: 250(ml), Frequency: od, Duration: 15 Days | | 2 | Intervention Arm | Procedure | - | agnikarma, अग्निकर्म | (Procedure Reference: Sushrutha Samhitha Sutrasthana 12 Chapter., Procedure details: Procedure Reference: sushrutha samhitha sutrastana 11 chapter, Procedure details: Agnikarma for 4 sittings with an interval of 7 days Minimum 15 bindus per sitting & 0.5cm gap between each dagdha should be done.Yashtimadhu grta application after the procedure.))
(1) Medicine Name: Yashtimadhu grta, Reference: Sushrutha samhitha 5 chapter, Route: Topical, Dosage Form: Ghrita, Dose: 10(g), Frequency: od, Duration: 1 Months |
|
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients between age group 30-70 years of either gender.
2.Patient suffering from pain, stiffness, numbness irrespective to demographic data.
3.X-ray investigation with reduction in intervertebral disc space, loss of lordosis and presence of lumbar scoliosis taken for the study.
4.Patients who are of niramaja condition included.
|
|
| ExclusionCriteria |
| Details |
1.Patients below 30 years and above 70 years.
2.Patients of uncontrolled diabetes mellitus (RBS above 150mg/dl), R.A. (Rheumatoid arthritis) positive, hypertension.
3.Other diseases like paralysis, Parkinson’s disease, severe anaemia, cardiac diseases, renal diseases and endocrine diseases, severe anaemia and Malignancy.
4.Pregnant/lactating female.
5.Agnikarma Ayogya patients as per classics i.e. Pitta Prakruti diseased with Rakta-Pitta, Atisara, Durbala, Bheeru, Vranita, Aswedya and those having srotorodha, balabramsha.
6.Other diseases like sacroiliac joint arthritis, lymphomas, pelvic malignancy, etc., patients will be excluded.
7.Patients suffering from trauma,fracture, systemic diseases, Sciatica with neurological damage, contraindications to Agnikarma such as patients affected with multiple wounds, sciatica with SLR test positive less than 30°and more than 70°.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in pain stiffness numbness over lumbar region
|
1st day 7th day 14th day 21st day 28th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Absence of recurrence in followup period. |
60 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "43"
Final Enrollment numbers achieved (India)="43" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| Date of Study Completion (India) |
30/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Conclusion
The present study was conducted to
evaluate and compare the therapeutic effects of Agnikarma and Katibasti
with Devadarubaladi Taila in the management of Katisandhigata Vata (Lumbar
Spondylosis). Based on clinical assessments and statistical analysis of the
results, the following conclusions were drawn:
·
Both
Agnikarma with Panchadhathu Shalaka and Katibasti with Devadarubaladi
Taila provided clinical relief from pain, numbness, improved range of
motion of lumbar region and quality of life by improving daily functional
activities.
·
Agnikarma was found to be effective in
reducing pain and numbness whereas Katibasti produced better outcomes in
stiffness.
·
Statistically
highly significant improvements were observed in patients of both groups
individually. When comparing the two groups, statistically non-significant
differences in all parameters except lumbar extension where Agnikarma
showed high significance.
·
Both
treatments are cost-effective, minimally invasive, non-pharmacological and can
be conveniently administered in an OPD setting.
·
No
adverse effects were reported during the procedures or throughout the follow-up
period.
Therefore, the null hypothesis is
accepted, i.e., Agnikarma and Katibasthi are equally effective in
the symptomatic management of Katisandhigata Vata (Lumbar Spondylosis).
|