| CTRI Number |
CTRI/2025/03/081631 [Registered on: 04/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison study of Yuktharatha basti and Erandamooladi basti in Katishoola, Non-Specific Low back pain. |
|
Scientific Title of Study
|
A comparative clinical study on the efficacy of Yuktharatha
basti and Erandamooladi basti in Katishoola, Non-Specific Low back pain.
|
| 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 Harshitha H |
| Designation |
2 nd year PG scholar |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital |
| Address |
Department of Panchakarma Shri Dharmasthala Manjunatheshwara
Institute of Ayurveda and Hospital OPD 13 and OPD 26 Anchepalya Bengaluru
Karnataka 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
9964693219 |
| Fax |
|
| Email |
harshithagowda2104@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arub B Jainer |
| Designation |
Associate professor |
| Affiliation |
Department of Panchakarma Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital |
| Address |
Department of Panchakarma Shri Dharmasthala Manjunatheshwara
Institute of Ayurveda and Hospital OPD 13 Anchepalya Bengaluru
Karnataka 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
9900940333 |
| Fax |
|
| Email |
draruns@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arub B Jainer |
| Designation |
Associate professor |
| Affiliation |
Department of Panchakarma Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital |
| Address |
Department of Panchakarma Shri Dharmasthala Manjunatheshwara
Institute of Ayurveda and Hospital OPD 13 Anchepalya Bengaluru
Karnataka 560074
Bangalore
KARNATAKA
560074
India |
| Phone |
9900940333 |
| Fax |
|
| Email |
draruns@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthala Manjunatheshwara
Institute of Ayurveda and Hospital
Bengaluru, 560074 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Dr Harshitha H |
| Address |
Department of Panchakarma Shri Dharmasthala Manjunatheshwara
Institute of Ayurveda and Hospital OPD 13 and OPD 26 Anchepalya Bengaluru 560074,Karnataka India |
| Type of Sponsor |
Other [(Self)] |
|
|
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 Harsgitha H |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital |
OPD 13 and OPD 26 Anchepalya Bengaluru
Karnataka 560074
Bangalore
KARNATAKA |
9964693219
harshithagowda2104@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:7||Osteopathic. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Erandamooladi niruha ingredients, Reference: charak siddhi chapter3, Route: Rectal, Dosage Form: Kwatha/ Kashaya, Dose: 595(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 8 Days, anupAna/sahapAna: No, Additional Information: -anuvasan basti with panchathiktaka ghrita 40 ml and ashwagandha ghrita 40 ml given after food in rectal route | | 2 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charaka siddhi stana 3 , Procedure details: Patient laying in left lateral position
Prepared enema is inserted through anal route.
Avoid astamahavarjakara bhava)
| | 3 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Shrushta samhita chikista stana 38, Procedure details: Patient laying in left lateral position Prepared enema is inserted through anal route. Avoid astamahavarjakara bhava)
)
(1) Medicine Name: yuktharatha basti ingredients, Reference: sushrutha chikitsa chapter 38, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 600(ml), Frequency: od, Duration: 8 Days | | 4 | Intervention Arm | Drug | Classical | | (1) Medicine Name: yuktharatha basti ingredients, Reference: sushrutha chikitsa 38, Route: Rectal, Dosage Form: Kwatha/ Kashaya, Dose: 600(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 8 Days, anupAna/sahapAna: No, Additional Information: -anuvasan basti with panchathiktaka ghrita 40 ml and ashwagandha ghrita 40 ml given after food in rectal route |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients fulfilling the diagnostic criteria.
2. Patient of male and female gender within the age group of 25 years to 50 years.
3. Patients complaining of low back less than 1 year.
4. Patients who have more frequency of traveling.
5. Patients who are yogya for basti.
6.Patients who are voluntarily willing to sign informed consent. |
|
| ExclusionCriteria |
| Details |
1.Congenital deformities of spine
2.Patients having Spinal tumour, Malignant diseases of the pelvis, Tuberculosis of vertebral bodies
3.Lumbar region surgery or implanted instrumentation
4.Patients having Compressive fracture, Ankylosing spondylitis, Spondylolisthesis, IVDP, Kati graha, Gridrasi.
5.Any other systemic illness like uncontrolled DM that interferes with treatment.
6.Pregnancy and Lactating women, Lucchorea, IUCD.
7.Patients who are Anasthapya are excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| •Reduction in pain-assessment through VAS score. |
0th day - Before treatment
9th day - 1st assessment After treatment
24th day - 2nd assessment 1st follow up final assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • Improving the quality of life related to Katishoola through Oswestry low back disability questionnaire |
0th day - Before treatment
9th day - 1st assessment After treatment
24th day - 2nd assessment 1st follow up final assessment |
|
|
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)
|
11/03/2025 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Low back is the main structural support & it provides balance to maintain an upright posture, Non-specific low back pain affects people of all ages and is a leading contributor to disease burden worldwide, it doesn’t have a known path anatomical cause, and treatment focuses on reducing pain and its consequences. Nonspecific low back pain is a condition which is characterized by dull or sharp pain it is often associated with burning sensation and numbness. which leads to restricted activity, reduced work capacity, and quality of everyday living, and daily life turns into misery. Kati is the seat of Vata dosha and the root cause of the disease is aggravated by Vata, Katishoola is an ailment that is caused due to the vitiation of vata, kapha doshas, But the description of this observed in some disorders like Trika graha, Prusta graha, Gridhrasi which is comprehended under Vata Vyadhi. According to The Global Burden of Disease Study 2021, the prevalence of low back pain is 95%2. A systemic review and meta-analysis on the prevalence of low back pain in India reviews shows. The pooled prevalence rates were highest among females, the rural population, and elementary workers3. Basti Karma is the prime treatment modality in VataVyadhis. It is considered the ArdhaChikitsa, it has already been proven to be efficacious in the treatment of vata vyadhis. In this study an attempt is made to know the effect of Yuktharatha basti and Erandamooladi basti in the management of pain in katishoola Hence ‘A Comparative Clinical Study to Evaluate the Effect of Yuktharatha Basti and Erandamooladi Basti in Katishoola, Non Specific Low Back Pain.’ an effort is made. |