CTRI/2026/01/100529 [Registered on: 08/01/2026] Trial Registered Prospectively
Last Modified On:
07/01/2026
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Randomized, Parallel Group Trial
Public Title of Study
A Clinical study to compare the efficacy of Vaitarana and Siddha Basti mentioned by Vangasena along with Dhanyamla Dhara in Amavata(Rheumatoid Arthritis).
Scientific Title of Study
“A Randomized open labelled clinical study to compare the efficacy of Vangasenokta Siddha Basti and Dhanyamla Dhara with Vangasenokta Vaitarana Basti and Dhanyamla Dhara in the management of Amavata Vis-a-vis Rheumatoid Arthritis."
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 Manojna S Maliye
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
Bangalore KARNATAKA 560082 India
Phone
8951560339
Fax
Email
manogna.s.m@gmail.com
Details of Contact Person Scientific Query
Name
Dr Madhushree H. S.
Designation
Professor
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
Bangalore KARNATAKA 560082 India
Phone
9916058006
Fax
Email
drmadhushreehs@rediffmail.com
Details of Contact Person Public Query
Name
Dr Madhushree H.S.
Designation
Professor
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
Bangalore KARNATAKA 560082 India
Phone
9916058006
Fax
Email
drmadhushreehs@rediffmail.com
Source of Monetary or Material Support
Sri Sri College of Ayurvedic Science and Research, 21st km, P.O. Udayapura, Kanakapura road, Bangalore, 560082, Karnataka, India.
Primary Sponsor
Name
Dr.Manojna S Maliye
Address
Sri Sri College of Ayurvedic Science and Research, Bangalore.
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
DrManojna S Maliye
Sri Sri College of Ayurvedic and Research Hospital, Bangalore
Room no-8,
Panchakarma OPD, Sri
Sri College of Ayurvedic
science and Research
Hospital, 21st K.M.
Kanakapura Road,
Udayapura.
Bangalore
KARNATAKA Bangalore KARNATAKA
(Procedure Reference: Panchakarma Illustrated by Dr. G Shrinivasa Acharya, Procedure details: Procedure details: NIRUHABASTI- POORVAKARMA - 1) vishesha poorvakarma - sarvanga dhanyamla dhara will be done. 2) for niruha basti -Sambhara Sangraha –Enema can-1, rubber catheter-1, Niruha Basti Dravya - Vaitarana basti- Amlika- 1 Pala (48 ml), Guda-1 shukti (24 g),Saindhava lavana- 1 karsha( 12g), Gomutra- 1 kudava( 192ml) moorchita tila taila - ishat -30-40ml Total- 316ml, Hot water bath (to warm Moorchita tila taila -Q.S) - 1, Hot water bag-1, Cotton swab- 1, Gloves- 1 pair, Therapists- 2. Preparation of Basti Yantra and Basti Netra – The enema can fit with its tube along with a rubber catheter which is fitted to the free end of the nozzle will be used for Niruha Basti. 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 Moorchita 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 4½ - 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 lie down in left lateral position, and gentle tapping over the buttocks will be done. Then subject will be asked to lie in supine position and rub hispalms briskly against each other, at the same time the therapist will rub the sole vigorously followed by foot end elevation to prevent early Pratyagamana of Basti Dravya. Instructions will be given to pass the bowel after getting the Vega, followed by warm water bath and advised diet.) (1) Medicine Name: vaitarana basti, Reference: vangasena bastikarmadhikara, Route: Rectal, Dosage Form: Not Applicable, Dose: 316(ml), Frequency: od, Duration: 3 Days(2) Medicine Name: dhanyamla, Reference: sahasrayoga kashaya prakarana, Route: Topical, Dosage Form: Not Applicable, Dose: 5000(ml), Frequency: od, Duration: 8 Days
2
Intervention Arm
Procedure
-
yoga-bastiH, योग-बस्तिः
(Procedure Reference: Panchakarma Illustrated by Dr. G Shrinivasa Acharya, Procedure details: Procedure details: NIRUHABASTI- POORVAKARMA - 1) Vishesha Poorvakarma - Sarvanga Dhanyamla Dhara will be done. 2) poorvakarma for niruha Basti - Sambhara Sangraha –Enema can-1, rubber catheter-1, Niruha Basti Dravya - Siddha Basti- Amlika- 1 Pala (48 ml),Guda-1 Pala (48 g),Saindhava lavana- 1 karsha( 12g), Shatapushpa kalka- 1 karsha( 12g), Gomutra- 8 pala ( 384ml) Total- 504ml, Hot water bath (to warm Moorchita tila taila -Q.S) - 1, Hot water bag-1, Cotton swab- 1, Gloves- 1 pair, Therapists- 2. Preparation of Basti Yantra and Basti Netra – The enema can fit with its tube along with a rubber catheter which is fitted to the free end of the nozzle will be used for Niruha Basti. 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 Moorchita 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 4½ - 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 lie down in left lateral position, and gentle tapping over the buttocks will be done. Then subject will be asked to lie in supine position and rub hispalms briskly against each other, at the same time the therapist will rub the sole vigorously followed by foot end elevation to prevent early Pratyagamana of Basti Dravya. Instructions will be given to pass the bowel after getting the Vega, followed by warm water bath and advised diet.
) (1) Medicine Name: siddha basti, Reference: Vangasena Bastikarmadhikara, Route: Rectal, Dosage Form: Not Applicable, Dose: 504(ml), Frequency: od, Duration: 3 Days(2) Medicine Name: Dhanyamla, Reference: Sahasrayoga Kashaya prakarana, Route: Topical, Dosage Form: Not Applicable, Dose: 5000(ml), Frequency: od, Duration: 8 Days
3
Comparator Arm
Procedure
-
yoga-bastiH, योग-बस्तिः
(Procedure Reference: Panchakarma Illustrated by Dr. G Shrinivasa Acharya, Procedure details: ANUVASANA BASTI POORVA KARMA : Sambhara Sangraha –Anuvasana Basti Yantra-100 ml sterile syringe with rubber catheter- 1, Anuvasana Basti Dravya-Moorchita Tila Taila – 72 ml, Hot water bath (to warm the Sneha Dravya)-1, Bowl/Kidney Tray-1, Artery forceps-1, Hot water bag-1, Cotton swab- 1, Gloves- 1 pair, Droni-1, Therapists- 2. 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 the 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 Moorchita Tila Taila will be given followed by Sthanika Swedana 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 Moorchita Tila Tailafor 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. PASCHATKARMA Lower back will be tappedafter which the subject willbe 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: Moorchita tila taila , Reference: Bhaishajya Ratnavali , Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Duration: 5 Days
4
Intervention Arm
Procedure
-
yoga-bastiH, योग-बस्तिः
(Procedure Reference: Panchakarma Illustrated by Dr. G Shrinivasa Acharya, Procedure details: Procedure details: ANUVASANA BASTI POORVA KARMA : Sambhara Sangraha –Anuvasana Basti Yantra-100 ml sterile syringe with rubber catheter- 1, Anuvasana Basti Dravya-Moorchita Tila Taila – 72 ml, Hot water bath (to warm the Sneha Dravya)-1, Bowl/Kidney Tray-1, Artery forceps-1, Hot water bag-1, Cotton swab- 1, Gloves- 1 pair, Droni-1, Therapists- 2. 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 the 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 Moorchita Tila Taila will be given followed by Sthanika Swedana 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 Moorchita Tila Tailafor 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. PASCHATKARMA Lower back will be tappedafter 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: Moorchita tila taila, Reference: Bhaishajya Ratnavali, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Duration: 5 Days
Inclusion Criteria
Age From
20.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
1)Subjects of age group between 20 to 60 yrs, of both genders with chronicity equal to or less than five-year duration will be selected for the study.
2)Subjects of Amavata diagnosed on the basis of signs & symptoms described in Ayurvedic classics will be selected for the study.
3)Subjects diagnosed as Amavata with features of Rheumatoid arthritis as specified in European League Against Rheumatism/ American College of Rheumatology 2010 criteria that is 2010 ACR-EULAR diagnostic criteria24 will be selected for the study.
4)Subjects indicated for Basti Karma and Dhanyamla Dhara will be selected for the study.
5)Considering disease activity and functional impairment STAGE-1, STAGE-2
6)Subjects voluntarily willing to give written consent and participate in the study.
ExclusionCriteria
Details
1)Subjects of both genders with chronicity of disease more than 5 years with any joint deformity.
2)Subjects with any systemic disease or condition that would potentially interfere with the course of treatment.
3)Subjects contraindicated for Basti Karma and Dhanyamla Dhara.
4)Subjects with the signs and symptoms of Pravruddha Amavata with joint deformities STAGE-3, STAGE-4
5)Pregnant and lactating women.
Method of Generating Random Sequence
Coin toss, Lottery, toss of dice, shuffling cards etc
Method of Concealment
An Open list of random numbers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Significant decrease in symptoms of Amavata vis-a-vis Rheumatoid arthritis assessed based on subjective parameters like Sandhishoola, Sandhistabdhata, Sandhishopha and other Samanya Lakshanas like Angamarda, Aruchi, Trushna etc., ) and objective parameters ( like tenderness in joints, warmth in joints, Disease activity score 28 or DAS28, general functional capacity and Barthel’s index)
all the parameters will be assessed at 3 different time points, namely 0th day, 8th day and 16th day.
Secondary Outcome
Outcome
TimePoints
Generation of in-depth analysed data on the different aspects of the disease.
Generation of data on quality of life with the test treatment modalities assessed based on Barthel’s index.
Generation of data on possible unexpected/adverse drug reactions or events.
0th day, 8th day, 16th 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 4
Date of First Enrollment (India)
22/01/2026
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="0" Days="0"
Recruitment Status of Trial (Global)
Not Yet Recruiting
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
In today’s day and age, we live in a competitive world with career
driven individuals who turn a blind eye towards their physical, mental, and
social wellbeing in order to succeed in attaining materialistic accolades. Failing
to follow healthy and disciplined dietary practices and seasonal regimens, tends
to lead them to an altered status of their digestion and metabolism that in
turn leads to the accumulation of Ama leading to several serious diseases.
Amavata is
one such crippling disease claiming a herculean loss of human power where there
is formation and deposition of Ama at all levels of body physiology.
Amavata was first described by Acharya Madhavakarawherein ‘Yugapat’ that pertains to
simultaneous vitiation of Vata and Kapha Dosha in the Koshta,
later entering the Trika Sandhi Pradesha leading to Gatra Stabdhata
and Trika Sandhi Vedana1.
In the 21st century, Rheumatoid arthritis (RA), that is said
to have a strong resemblance with the symptoms of Amavata has been more
common & distressing amongst all joint-related pathologies and is
characterised as an autoimmune and a systemic inflammatory disease with a
disabling and progressive course.Marking a prevalence rate of 0.24% 2
which has drastically increased up to 0.5% -1% over a decade, with a woman to
man ratio of 3:1. It is 4-5 times higher in women under 50 years, but after 60
years the ratio becomes approximately 2:1 globally. Family studies indicate a
genetic predisposition and patients with first-degree relatives possessing the
auto antibody are found to have 2 :1 time greater risk of developing severe
arthritis than the general population3.
Modern medicine, having
introduced the utility of NSAIDs, DMARDs, immunosuppressants and steroids has been
able to deliver only interim benefits to patients in terms of symptomatic
relief but no cure and with an addon of potential chances of developing co-
morbidities and having a negative impact on the immune system.
In Ayurveda, Siddha Basti
and Vaitarana Basti mentioned in Vangasena Samhita4,5
and Dhanyamla Dhara mentioned in Sahasrayogam6are
indicated in the mitigation of Amavata as all these modalities act as Vatakapha
Prashamana Chikitsas. Being the prime treatment for Vata Dosha and
rightly considered as Chikitsardha by our Acharyas, Basti Karma
has been chosen in view of both curative and preventive aspects of the disease.
Siddha Basti is said to have Rukshana, Lekhana, Amavata prashamana7
qualities whereas Vaitarana
Basti is indicated in Shoola, Amavata, Shopha of Kati, Uru, Prushta8
etc Hence this study is undertaken to compare the clinical efficacy of VangasenoktaSiddha Basti and Dhanyamla Dhara with VangasenoktaVaitarana
Basti and Dhanyamla Dhara in the management of Amavatavis-a-vis Rheumatoid
Arthritis.