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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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M629||Disorder of muscle, unspecified. Ayurveda Condition: VATASULAVYAPAT,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(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: --
2Comparator ArmDrugClassical(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.

 
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