CTRI/2026/01/102398 [Registered on: 29/01/2026] Trial Registered Prospectively
Last Modified On:
28/01/2026
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Drug Ayurveda
Study Design
Randomized, Parallel Group Trial
Public Title of Study
A comparative study of Ksheera Basti and Panchatikta Ksheera Basti in management of Janusandhigata Vata (knee joint osteoarthritis).
Scientific Title of Study
A randomized open labelled clinical study of Ksheera Basti in management of Janusandhigata Vata Vis-A-vis Osteoarthritis of knee joint and compare its efficacy with Panchatikta Ksheera Basti.
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 Jency Fernandez
Designation
PG Scholar
Affiliation
Sri Sri College Of Ayurvedic Science and Research Hospital
Address
Room no-8, Panchakarma OPD, Sri Sri College of Ayurvedic science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura
Bangalore KARNATAKA 560082 India
Phone
8921460186
Fax
Email
08jenfer1999@gmail.com
Details of Contact Person Scientific Query
Name
Dr Ganesh Puttur
Designation
Professor and HOD
Affiliation
Sri Sri College Of Ayurvedic Science and Research Hospital
Address
Room no-8, Panchakarma OPD, Sri Sri College of Ayurvedic science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura
Bangalore KARNATAKA 560082 India
Phone
9538176059
Fax
Email
drganeshputtur@gmail.com
Details of Contact Person Public Query
Name
Dr Ganesh Puttur
Designation
Professor and HOD
Affiliation
Sri Sri College Of Ayurvedic Science and Research Hospital
Address
Room no-8, Panchakarma OPD, Sri Sri College of Ayurvedic science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura
Bangalore KARNATAKA 560082 India
Phone
9538176059
Fax
Email
drganeshputtur@gmail.com
Source of Monetary or Material Support
Sri Sri College of Ayurvedic science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura. Bangalore , KARNATAKA , 560082 India
Primary Sponsor
Name
Dr JENCY FERNANDEZ
Address
Sri Sri College of Ayurvedic science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura. Bangalore , KARNATAKA , 560082 India
Type of Sponsor
Other [SELF]
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 Jency Fernandez
Sri Sri College of Ayurvedic Science and Research, Bengalore
Room no-8, Panchakarma OPD, Sri Sri College of Ayurvedic Science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura Bangalore KARNATAKA
8921460186
08jenfer1999@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Sri Sri Institutional Ethical Committee
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH,
(Procedure Reference: Panchakarma textbook by B A Lohit, Procedure details: KSHEERA BASTI PURVAKARMA SAMBHARA SANGRAHA: · Enema can-1, Rubber Catheter 1, Niruha Basti Dravya- Ksheera- 2 Prasruta, Madhu – 1 Prasruta, Guggulu Tiktaka Ghrita – 1 Prasruta, Murchita Tila Taila – 1 Prasruta, Hot Water Bath -1, Bowl/Kidney Tray-1, Artery Forceps-1, Hot Water Bag-1, Cotton Swab-1, Gloves-1 pair, Therapists-1.The already emulsified combination of the medicine is poured into the sterile enema can. The medicines also flow into the sterile tubing of the enema can making sure there are no air bubbles and distal end will be clamped with the artery forceps and kept ready. Preparation of the subject - Subject will be advised to be on empty stomach after ensuring the passing of motion, urine and flatus, subject will be made to lie down in supine position on the table. Sthanika Abhyanga with Murchita Tila Taila will be performed followed by Sthanika Swedana done with hot water bag over lower abdomen, back, thighs and buttocks of the subject. Position of the subject - Subject will be asked to lie in the left lateral position by keeping left leg straight and right leg flexed at the hip and knee joint. Left hand will be placed under the head. PRADHANAKARMA-The anal orifice of the subject will be smeared with the oil for lubrication with help of the cotton swab. The tip of the catheter will also be dipped in oil and smeared with the oil for lubrication. Therapist will hold the enema can in the left hand and with the right hand occluding the rubber tubing to prevent leakage. The catheter will be then gently introduced into the anal canal in the direction of the spine. About 4- 6 cm of the catheter will be inserted. Now without shaking or trembling and with uniform pressure Niruha Basti will be administered by elevating the enema can and releasing the occlusion from the rubber tubing. Before the enema can become completely empty the rubber tubing will be once again closed and the catheter will be withdrawn. PASCHATKARMA-Subject will be advised to pass the bowel after getting the urge, followed by warm water bath and advised light diet . Subjects will be advised to follow proper regimens of proper Parihara Kala for 20 days.
) (1) Medicine Name: KSHEERA BASTI, Reference: Charaka. Charaka Samhita, Siddhi Sthana, Chapter 8, Verse 4. Edited by Yadavji Trikamji Acharya. Reprint ed. Varanasi: Chaukhambha Orientalia; 2014., Route: Rectal, Dosage Form: Not Applicable, Dose: 486(ml), Frequency: od, Duration: 6 Days
(Procedure Reference: Panchakarma textbook by B A Lohit, Procedure details: PANCHATIKTA KSHEERA BASTI PURVAKARMA SAMBHARA SANGRAHA: Enema can-1, Rubber Catheter 1, Niruha
Basti Dravya- Madhu -1 Prasruta, Saindhava6 g, Shatapushpa – 12g, Guggulu Tiktaka Ghrita -1 Prasruta, Panchatikta Ksheera Kashaya – 2 Prasruta, Hot Water Bath- 1 , Bowl/Kidney Tray-1, Artery Forceps-1,Hot Water Bag-1, Cotton Swab-1, Gloves-1Pair,Therapists-1.The already emulsified combination of the medicine is poured into the sterile enema can. The medicines also flow into the sterile tubing of the enema can making sure there are no air bubbles and distal end will be clamped with the artery forceps and kept ready. Preparation of the subject - Subject will be advised to be on empty stomach after ensuring the passing of motion, urine and flatus, subject will be made to lie down in supine position on the table. Sthanika Abhyanga with Murchita Tila Taila will be performed followed by Sthanika Swedana done with hot water bag over lower abdomen, back, thighs and buttocks of the subject. Position of the subject - Subject will be asked to lie in the left lateral position by keeping left leg straight and right leg flexed at the hip and knee joint. Left hand will be placed under the head. PRADHANAKARMA-The anal orifice of the subject will be smeared with the oil for lubrication with help of the cotton swab. The tip of the catheter will also be dipped in oil and smeared with the oil for lubrication. Therapist will hold the enema can in the left hand and with the right hand occluding the rubber tubing to prevent leakage. The catheter will be then gently introduced into the anal canal in the direction of the spine. About 4- 6 cm of the catheter will be inserted. Now without shaking or trembling and with uniform pressure Niruha Basti will be administered by elevating the enema can and releasing the occlusion from the rubber tubing. Before the enema can become completely empty the rubber tubing will be once again closed and the catheter will be withdrawn. PASCHATKARMA-Subject will be advised to pass the bowel after getting the urge, followed by warm water bath and advised light diet . Subjects will be advised to follow proper regimens of proper Parihara Kala for 20 days.) (1) Medicine Name: PANCHATIKTA KSHEERA BASTI, Reference: Charaka Samhita, Siddhi Sthana, Chapter 8,, Route: Rectal, Dosage Form: Not Applicable, Dose: 552(ml), Frequency: od, Duration: 6 Days
3
Comparator Arm
Procedure
-
anuvAsana-bastiH, अनुवासन-बस्तिः
(Procedure Reference: Panchakarma textbook by B A Lohit, Procedure details: Anuvasana Basti Yantra- 100 ml sterile syringe with rubber catheter- 1,Anuvasana Basti Dravya- Guggulu Tiktaka Ghrita – 72 ml, Hot water bath -1, Bowl/Kidney Tray-1, Artery forceps-1, Hot water bag-1, Cotton swab- 1, Gloves- 1 pair, Droni-1, Therapists- 1. Preparation of Basti Yantra and Basti Netra -100ml syringe along with the rubber catheter fitted to the free end of the syringe will be used for Anuvasana Basti. The mentioned quantity of medicine is indirectly warmed using hot water bath and is filled inside he sterile syringe.The medicine will also flow into the catheter attached to the syringe making sure there are no air bubbles. The distal end of catheter will be clamped with artery forceps and is kept ready. Preparation of the subject - Subject will be asked to come for the treatment immediately after food, after ensuring the passing of motion, urine and flatus, subject will be made to lie down in supine position on the table. Sthanika Abhyanga with Murchita Tila Taila will be given followed by Sthanika Swedana with hot waterbag over lower abdomen, back, thighs and buttocks of the subject.Position of the subject -Subject will be asked to lie in the left lateral position by keeping left leg straight and right leg flexed at the hip and knee joint. Left hand will be placed under the head. PRADHANA KARMA : The anal orifice of the subject will be smeared with Murchita Tila Taila for lubrication with help of the cotton swab. The tip of the catheter will also be dipped in oil and smeared with the oil for lubrication. Therapist will hold the syringe in the left hand and with the right hand occluding the rubber catheter to prevent leakage. The catheter will be then gently introduced into the anal canal in the direction of the spine. Now without shaking or trembling and with uniform pressure. Anuvasana Basti will be administered by pushing the syringe and releasing the pressure from the rubber catheter. Before the syringe become completely empty the rubber catheter will be once again closed and will be withdrawn. PASCHAT KARMA : Lower back will be tapped after which the subject will be asked to lie in supine position with foot end elevation, abdomen will be massaged in anticlockwise direction to increase the time of retention. Instructions will be given to pass the bowel after getting the Vega.) (1) Medicine Name: GUGGULU TIKTAKA GHRITA, Reference: Govindadasa. Visphota Chikitsa, Verse 257. Edited by Siddhinandan Bhaishajya Mishra. Ratnavali, Reprint ed. Varanasi: Chaukhambha Surbharati Prakashan; 2010., Route: Rectal, Dosage Form: Not Applicable, Dose: 72(ml), Frequency: od, Duration: 10 Days
4
Intervention Arm
Procedure
-
anuvAsana-bastiH, अनुवासन-बस्तिः
(Procedure Reference: Panchakarma textbook by B A Lohit, Procedure details: Anuvasana Basti Yantra- 100 ml sterile syringe with rubber catheter- 1,Anuvasana Basti Dravya- Guggulu Tiktaka Ghrita – 72 ml, Hot water bath -1, Bowl/Kidney Tray-1, Artery forceps-1, Hot water bag-1, Cotton swab- 1, Gloves- 1 pair, Droni-1, Therapists- 1. Preparation of Basti Yantra and Basti Netra -100ml syringe along with the rubber catheter fitted to the free end of the syringe will be used for Anuvasana Basti. The mentioned quantity of medicine is indirectly warmed using hot water bath and is filled inside he sterile syringe.The medicine will also flow into the catheter attached to the syringe making sure there are no air bubbles. The distal end of catheter will be clamped with artery forceps and is kept ready. Preparation of the subject - Subject will be asked to come for the treatment immediately after food, after ensuring the passing of motion, urine and flatus, subject will be made to lie down in supine position on the table. Sthanika Abhyanga with Murchita Tila Taila will be given followed by Sthanika Swedana with hot waterbag over lower abdomen, back, thighs and buttocks of the subject.Position of the subject -Subject will be asked to lie in the left lateral position by keeping left leg straight and right leg flexed at the hip and knee joint. Left hand will be placed under the head. PRADHANA KARMA : The anal orifice of the subject will be smeared with Murchita Tila Taila for lubrication with help of the cotton swab. The tip of the catheter will also be dipped in oil and smeared with the oil for lubrication. Therapist will hold the syringe in the left hand and with the right hand occluding the rubber catheter to prevent leakage. The catheter will be then gently introduced into the anal canal in the direction of the spine. Now without shaking or trembling and with uniform pressure. Anuvasana Basti will be administered by pushing the syringe and releasing the pressure from the rubber catheter. Before the syringe become completely empty the rubber catheter will be once again closed and will be withdrawn. PASCHAT KARMA : Lower back will be tapped after which the subject will be asked to lie in supine position with foot end elevation, abdomen will be massaged in anticlockwise direction to increase the time of retention. Instructions will be given to pass the bowel after getting the Vega.) (1) Medicine Name: GUGGULU , Reference: Govindadasa. Visphota Chikitsa, Verse 257. Edited by Siddhinandan Bhaishajya Mishra. Ratnavali, Reprint ed. Varanasi: Chaukhambha Surbharati Prakashan; 2010., Route: Rectal, Dosage Form: Not Applicable, Dose: 72(ml), Frequency: od, Duration: 10 Days
Inclusion Criteria
Age From
40.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
Subjects of age group between 40-65 years, irrespective of gender, religion, occupation
and socioeconomic status.
Subjects fit for Basti.
Subjects who are willing to give a written consent for the treatment.
Subjects diagnosed with Janusandhigata Vata with features, Vatapurnadrutisparsha
Shotha ,Sandhi Atopa and Prasarana Akunchana Pravrutthi Savedana.
ExclusionCriteria
Details
Condition associated with fracture, and other systemic illness that interfere with the
treatment protocol.
Subjects undergoing concurrent medications .
Pregnant and lactating women.
Method of Generating Random Sequence
Coin toss, Lottery, toss of dice, shuffling cards etc
Method of Concealment
Alternation
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To evaluateand compare the efficacy of Ksheera Basti and Panchatikta Ksheera Basti in Janusandhigata Vata vis-à-vis Osteoarthritis of knee joint on the basis of subjective parameters (VAS and WOMAC) and objective parameters (range of movement and functional ability) in the institute’s clinical set up.
0th day,
11th day.
31th day
Secondary Outcome
Outcome
TimePoints
To assess the improvement in quality of life in based on OAKHQOL (according to
WHO).
To Record and Report the of adverse effects of drug/event or both during the study period if any.
0th day,
11th day.
31th day
Target Sample Size
Total Sample Size="30" Sample Size from India="30" 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)
09/02/2026
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="1" Months="6" 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
Osteoarthritis is the most common articular disorder, which keeps an insidious attack and runs for many years causing the loss of function as well as deformity of the joints, especially weight bearing joints like the knee joint. Knee osteoarthritis is a major cause of morbidity and chronic disability. OA is a prevalent, progressively developing joint disorder that notably affects middle-aged and older individuals, substantially impacting their quality of life and ability to perform daily activities.
In Ayurveda, Sandhigata Vata is mentioned as one of the Vatavyadhi . The
symptoms of Janusandhigata Vata mentioned are Vatapoorna Drutisparsha Shotha
(Feeling of touching air-filled pocket), Sandhi Shoola, (Joint pain), Atopa
(Crepitus), and Prasarana Akunchana Pravrutthi Savedana (Painful extension and
flexion).
Hence, there is a need to explore for various other treatment options which will help in delaying the degenerative process at the level of knee joint with significant regression in the pain, in turn improving the quality of life of the individual. In Ayurveda, Tikta Ksheera Basti are considered as the best line of treatment mentioned for Asthi Ashrita Vyadhis. Many scientific studies conducted revealed greater efficacy of Tikta Ksheera Basti in Janusandhigata Vata. Ksheera Basti, which is mentioned by Acharya Charaka has the Phalashruti of Vataghna and Balakara.