| CTRI Number |
CTRI/2026/02/104972 [Registered on: 27/02/2026] Trial Registered Prospectively |
| Last Modified On: |
26/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Other (Specify) [Procedure] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparative Study to Assess the Effectiveness of Panchamoola Kashaya as enema and Cow’s Milk Vaitarana Enema in Patients with Low Back Pain. |
|
Scientific Title of Study
|
“A Comparative Clinical Study to Evaluate the Efficacy of Panchamoola Kashaya Basti and Go-Ksheera Vaitarana Basti in the Management of Katishoola with Special Reference to 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 Megha M Y |
| Designation |
PG Scholar |
| Affiliation |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College And Hospital |
| Address |
SJGAMCH Koppal
OPD no 04 DEPT of panchakarma, shree jagadguru
gavisiddeshwara ayurvedic medical college and hospital koppal
583231
OPD no 04 DEPT of panchakarma, shree jagadguru
gavisiddeshwara ayurvedic medical college and hospital koppal
583231
Koppal KARNATAKA 583231 India |
| Phone |
9743805678 |
| Fax |
|
| Email |
meghagadagin@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Latha L U |
| Designation |
Associate Proffessor |
| Affiliation |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College And Hospital |
| Address |
SJGAMCH Koppal
OPD no 04 DEPT of panchakarma, shree jagadguru
gavisiddeshwara ayurvedic medical college and hospital koppal
583231
OPD no 04 DEPT of panchakarma, shree jagadguru
gavisiddeshwara ayurvedic medical college and hospital koppal
583231
KARNATAKA 583231 India |
| Phone |
9743805678 |
| Fax |
|
| Email |
dr.lathalu7@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Megha M Y |
| Designation |
PG Scholar |
| Affiliation |
Shree Jagadguru Gavisiddeshwara Ayurvedic Medical College And Hospital |
| Address |
SJGAMCH Koppal
OPD no 04 DEPT of panchakarma, shree jagadguru
gavisiddeshwara ayurvedic medical college and hospital koppal
583231
OPD no 04 DEPT of panchakarma, shree jagadguru
gavisiddeshwara ayurvedic medical college and hospital koppal
583231
KARNATAKA 583231 India |
| Phone |
9743805678 |
| Fax |
|
| Email |
meghagadagin@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Megha M Y |
| Address |
OPD No 04 Department of Panchakarma, Shree Jagadguru Gavisiddeshwra Ayurvedic Medical College and Hospital , Koppal 583231 |
| Type of Sponsor |
Private 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 Megha M Y |
Shree Jagadguru Gavisiddheshwara Ayurvedic Medical College and Hospital |
OPD no 04 DEPT of panchakarma, shree jagadguru
gavisiddeshwara ayurvedic medical college and hospital koppal
583231
Koppal KARNATAKA |
9743805678
meghagadagin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethival Committee SJGAMC&H Koppal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M629||Disorder of muscle, unspecified. Ayurveda Condition: VATASULAVYAPAT, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Panchamoola kashaya, Reference: Ashtanga Hrudaya, Route: Rectal, Dosage Form: Kwatha/ Kashaya, Dose: 480(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 8 Days, anupAna/sahapAna: No, Additional Information: -- | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Go Ksheera Vaitarana, Reference: Vangasena, Route: Rectal, Dosage Form: Ksheerpaka, Dose: 350(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 8 Days, anupAna/sahapAna: No, Additional Information: -- |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects suffering from Kati shoola more than 15 days
2.Subjects will be selected irrespective of their gender.
3.Subjects aged between 20 to 60 years.
4. Subjects fit for Basti Karma. |
|
| ExclusionCriteria |
| Details |
1.Pregnant women and lactating mothers.
2.Any systemic disorders which interfere with the course of the treatment.
3.Subjects of Uncontrolled Hypertension and Diabetes Mellitus.
4.Subjects unfit for Basti Karma
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There is significant effect of Panchamoola kashaya Basti over Goksheera Vaitarana Basti in Katishoola |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduced muscle stiffness & imprvement in range of movement in lumbar spine. |
28 Days |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/05/2026 |
| 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="3" Months="4" 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
|
Low back pain (LBP) is a musculoskeletal disorder involving muscles, ligaments, nerves, intervertebral discs and bony structure of the spine. Although most individuals experience at least one episode of acute LBP during their lifetime. Persistent pain alters activities of daily living, impairs body functions and significantly affects quality of life. Earlier considered a Geriatric problem, Katishoola is now increasingly prevalent among the younger, working age population due to lack of exercise, improper posture, prolonged sitting and occupational hazards. In India, approximately 70-80% of adults experience LBP at some point in their lives, leading to considerable loss of productivity and functional disability .According to the WHO, in 2020, LBP affected around 619 million people globally, and the burden is projected to increase to 843 million by 2050 . In 2025, it remains as one of the leading causes of years lived with disability worldwide, contributing substantially to economic burden through health care costs and work absenteeism. Katishoola is not described as a distinct disease entity in the Brihatraree. However, Acharya Charaka, while explaining Anukta Vikara, states that vitiated Vata Dosha, when localized in any part of body, produces symptoms such as shoola, shosha and supti, which are considered manifestations of Vata Vyadhi. Basti Karma is regarded as the most effective thearapy for vata vyadhi. Acharya Vagbhata describes basti as ardha chiktsa due to its systemic action on Vata dosha6 . Hence, Basti plays a pivotal role in the management of Katishoola, by correcting the gati of Vyana Vata. Acharya Vagbhata has described Panchamoola as a potent Vata-kaphahara dravya, possessing Kashaya-Tikta rasa, Ushna veerya, and Shothahara and Vedanasthapaka properties. Acharya Vangasena has advocated Goksheera Vaitarana Basti, which possesses Madhura rasa, Guru-Snigdha guna, Sheeta veerya, and Madhura vipaka, acting as Vatahara and Vedanastapaka. Contemporary management of katishoola largely offers symptomatic relief through analgesics and physiotherapy with limited long term efficacy and high recurrence rates. Panchamoola kashaya yoga basti, owing to its targeted vata-kaphahara and shothahara karma comparatively less ushna which is helpful in bala,vriddha persons and less tikshna than dashamoola, provides a focused and safer therapeutic approach for Katishoola, warranting systematic clinical evaluation. Therefore, taking these two treatment modalities an effort is made to treat, analyze and compare the efficacy of Panchamoola kashaya basti and Goksheera Vaitarana Basti in Katishoola. |