| CTRI Number |
CTRI/2024/03/064682 [Registered on: 22/03/2024] Trial Registered Prospectively |
| Last Modified On: |
25/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
role of ayurveda in the management of lumbar spondylosis |
|
Scientific Title of Study
|
Effect of sahachara taila anuvasan basti given on the same and alternate day of erandamuladi niruha basti under kala basti in the management of lumbar spondylosis (kati shoola)- 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 |
Anil Kumar |
| Designation |
MD Scholar |
| Affiliation |
ITRA Jamnagar |
| Address |
Department of panchakarma 4th floor ITRA
Jamnagar
GUJARAT
361008
India |
| Phone |
8562025234 |
| Fax |
|
| Email |
anilkhichar36@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul S Gandhi |
| Designation |
Assistant Professor |
| Affiliation |
ITRA Jamnagar |
| Address |
Department of panchakarma 4th floor ITRA
Jamnagar
GUJARAT
361008
India |
| Phone |
9427451634 |
| Fax |
|
| Email |
rsgandhi2003@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul S Gandhi |
| Designation |
Assistant Professor |
| Affiliation |
ITRA Jamnagar |
| Address |
Department of panchakarma 4th floor ITRA
GUJARAT
361008
India |
| Phone |
9427451634 |
| Fax |
|
| Email |
rsgandhi2003@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda Jamnagar 361008 |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda Jamnagar 361008 |
| Address |
Opposite B-Division Police Station, Gurudwara Road, 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 |
| Anil Kumar |
PG Hospital Institute of Teaching and Research in Ayurveda |
OPD 14 PG Hospital Institute of Teaching and Research in Ayurveda Jamnagar
Jamnagar
GUJARAT |
8562025234
anilkhichar36@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:M479||Spondylosis, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: charaka samhita , siddhi sthana , 3/38, Procedure details: The procedure of Niruha Basti and Anuvasana basti will be carried out as per the standard operative procedure (SOP) followed in the department.
• Anuvasana Basti – 120ml Sahachara Taila will be filled in an enema syringe. Then oleated rubber catheter will be attached to enema syringe and air will be removed. then rubber catheter will be introduced into the anus and Taila will be pushed inside to avoid entrance of Vayu.
• Asthapana Basti – Total amount of Erandamuladi Basti Dravya will)
(1) Medicine Name: erandamooladi basti, Reference: charaka samhita siddhi sthana 3/38, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 720(ml), Frequency: od, Duration: 10 Days | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: charaka samhita , sidhhi sthana 3/38, Procedure details: The procedure of Niruha Basti and Anuvasana basti will be carried out as per the standard operative procedure (SOP) followed in the department.
• Anuvasana Basti – 120ml Sahachara Taila will be filled in an enema syringe. Then oleated rubber catheter will be attached to enema syringe and air will be removed. then rubber catheter will be introduced into the anus and Taila will be pushed inside to avoid entrance of Vayu.
• Asthapana Basti – Total amount of Erandamuladi Basti Dravya will)
(1) Medicine Name: erandamooladi basti, Reference: charak siddhi sthana 3/38, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 720(ml), Frequency: od, Duration: 16 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting with any of the signs and symptoms of Lumbar spondylosis (Kati shoola).
Degenerative changes on X-ray LS Spine- AP, Lateral view.
Patients who are indicated for Basti Karma.
Willing and able to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Patients below 30 years and above 60 years of age.
Diagnosed patients of chronic diseases like, uncontrolled Diabetes mellitus, Rheumatoid arthritis, Ankylosing spondylitis, Psoriatic arthritis, Lumbar spondylitis, Lumbar spondylolisthesis.
Patients having spinal tumor, malignant diseases of the pelvis, tuberculosis of vertebral bodies, Congenital Anomalies like Spina Bifida.
Patients having fracture/dislocation, underwent recent lumbar surgery or implanted instrumentation or prostheses.
Pregnant and lactating women.
|
|
|
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 |
16 days for group A
10 days for group B |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Radiological changes |
16 days for group A
10 days for group B |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2024 |
| Date of Study Completion (India) |
01/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| 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)
|
The title of research project is EFFECT
OF SAHACHARA TAILA ANUVASANA BASTI GIVEN ON THE SAME AND ALTERNATE DAY
OF ERANDAMULADI NIRUHA BASTI UNDER KALA BASTI IN THE MANAGEMENT
OF LUMBAR SPONDYLOSIS (KATI SHOOLA)- AN OPEN LABELLED RANDOMISED
COMPARATIVE CLINICAL TRIAL.
Introduction:
There
are two different protocols suggesting use of Anuvasana Basti, after use
of Niruha Basti. Charakacharya and Dalhana mentions use of Anuvasana
Basti on
the same day of Niruha, to avoid Vata Dosha vitiation, and
Chakrapani mentions next day Anuvasana Basti, which is followed majorly
in practicality. Thus, the comparison of these two treatments is expected from
this study. The disease considered here is lumbar spondylosis, which is degenerative in nature; and
produces pain, stiffness and reduced ROM. Its prevalence is around 70% amongst
all musculoskeletal pains.
Aims
and objectives: To assess and compare the efficacy of Sahachara Taila Anuvasana Basti administered on the same day and alternate
day of Erandamuladi Niruha Basti under Kala Basti
in the management of Lumbar spondylosis (Kati Shoola). Materials
& Methods: The study
was initiated after ethical clearance from IEC and registration with CTRI. Total
30 patients enrolled in the study underwent randomization and 15 patients in
each group were allotted. All the participants were administered KalaBasti, with Anuvasana by Sahachara Taila-120 ml,
and Niruha by Erandamooladi Niruha Basti. In
Group A, Anuvasana Basti was given on next day of Niruha, while in Group B, same day Anuvasana
Basti was administered. The
treatment was adopted for 16 days in Group A, and 10 days in Group B.
Evaluation of efficacy in subjective and objective parameters, assessment of Basti pattern was carried out and statistical assessment was done. Results and Discussion: Results: Both the groups showed highly significant result
individually in all symptoms, while statistically significant results were
observed. Clinically, Group B was better than Group A in relieving pain (VAS),
ODI (Oswestry Disability Index) and ROM (Range of Motion). Group A showed
better result clinically in stiffness. Duscussion: In
Katishoola
(lumbar spondylosis), Vata with Aama/Kapha
Avarana is involved. Erandamooladi
Niruha Basti, being Kaphahara
and Vatanulomana, removes Avarana and clears Srotas. In ADAB, stronger Lekhana and Deepana
actions relieve stiffness better. In SDAB, same-day Anuvasana Basti
balances Vata through Snigdhata, improving pain (VAS),
ODI, and ROM. Follow up:Follow up was done after 15 days of treatment. Adverse effects:This treatment have no any unwanted effects. |