| CTRI Number |
CTRI/2025/10/096504 [Registered on: 28/10/2025] Trial Registered Prospectively |
| Last Modified On: |
25/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
“A Clinical Study to Evaluate the Effect of Kala Basti Treatment Using Dwipanchmooladi Niruha and Erand Taila Anuvasana in the Management of Amavata (Rheumatoid Arthritis)”
|
|
Scientific Title of Study
|
An Open Randomised Clinical Control study to asses the effect of kala basti krama with dwipanchamooladi niruh and Erand taila Erand taila anuvasan on the sign and aymptoms of amavata with special reference to 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 Jyoti Eknathrao Kharabe |
| Designation |
PG Scholar |
| Affiliation |
R. A. Podar ayurved medical college worli mumbai 400018 |
| Address |
Department Of Panchkarma
Opd No 07
R.A. Podar Ayurved Medical College,Mumbai Worli 400018
Maharashtra
India
Mumbai
MAHARASHTRA
400018
India |
| Phone |
7673970155 |
| Fax |
|
| Email |
kharabejyoti97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Bahatkar |
| Designation |
MD PhD, Head of Department of panchkarma |
| Affiliation |
Department Of Panchkarma Opd No. 07,M.A Podar hospital worli, mumbai 400018 |
| Address |
Department Of Panchkarma
Opd No. 07
M. A. Podar Hospital worli, mumbai 400018
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9881900560 |
| Fax |
|
| Email |
seemabahatkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema Bahatkar |
| Designation |
MD PhD, Head of Department of panchkarma |
| Affiliation |
Department Of Panchkarma Opd No. 07,M.A Podar hospital worli, mumbai 400018 |
| Address |
Department Of Panchkarma
Opd No. 07
M. A. Podar Hospital worli, mumbai 400018
Mumbai
MAHARASHTRA
400018
India |
| Phone |
9881900560 |
| Fax |
|
| Email |
seemabahatkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| M.A podar ayurved hospital,dr annie besant road worli mumbai 40018 |
|
|
Primary Sponsor
|
| Name |
M. A podar Hospital worli Mumbai 400018 |
| Address |
R. A. Podar Ayurved medical college worli Mumbai 400018 |
| Type of Sponsor |
Government 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 JYOTI EKNATHRAO KHARABE |
M A PODAR HOSPITAL WORLI,MUMBAI |
opd no.07 department panchkarma M.A.Podar hospital worli mumbai 400018
Mumbai
MAHARASHTRA |
7673970155
kharabejyoti97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional enthics commitee R.A. podar ayurved medical college worli mumbai 400018 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M249||Joint derangement, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: charak Sidhisthana3/19, Procedure details: patient is made to lie in left lateral position with right leg bend at knee. lubricates the tip of the catheter with oil. apply oil on the anal orifice .slowly insert the catheter into the anus ,slowly release the clip & allow the basti medicine ti flow into the rectum.carefully remove the catheter
1.medicine name-Dwipanchmooladi Niruha Basti
reference-Cha.Si3/58-70
route :-rectal
Dosage Form:-
Kwatha/kashaya-500ml
kalka-10gm
madhu10gm
Saidhav-5gm
til taila-120ml
kshara-2-10gm
frequency-OD
Duration-6days
2.medicine name-Erand taila(60ml) anuvasan basti
reference-sharangadhara samhita uttarkhada chapter5 sholka 4
route-rectal
dose -60ml
frequency -od
duration -9days
)
| | 2 | Comparator Arm | Procedure | - | bastikarma, बस्तिकर्म | (Procedure Reference: chakradata amavata 25/2-5, Procedure details: patient is made to lie in left lateral position with right leg bent at knee lubricate the tip of catheter with oil. apply oil on the anal orifice.slowly insert the catheter into the anus ,slowly release the clip & allow the basti medicine to flow into the rectum
carefully remove the catheter
medicine name-vaitaran basti
reference- chakradatta ,amavat 25/2-5
route-rectal
dosage 320ml -350ml
frequency-od
duration -7days)
|
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patient with the symptoms of amavata ,were taken for study
like sandhi shoola
sandhi shotha
sandhi satbdhata
patient who signed the informed return consent Rheumatoid factor positive patient |
|
| ExclusionCriteria |
| Details |
1.patients with other joints deformties or diseases which werw not related toamavata
2.fracture of any joint and needing surgical care were excluded
3.pregnancy,lactating womens
4 known cases of caediac disease,uncontrolled HTN,DM
Having severe crippling deformity,permanent joint deformity |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in the subjective and objective criteria of amvata |
day 32
follow up on day 0th,16th,24th,32th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to asses the effect of kala basti kram with dwipanchmooladi niruh and erand taila anuvasan on sign and symptoms of amavata |
day 32 |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
08/11/2025 |
| 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="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
|
in the present era of sophistication and mechanized lifestyle new disease are emerging as a result of unhealthy lifestyle. the predominant factors under constant change being the dietary habits and physical activity ,the incidence of lifestyle disease like amavata is increasing. bad dietary habits and sedentary lifestyle affect agni .weakness of agni leads to formation of ama.ama is indgested aadya rasa dhatu this ama produces various amapradooshaj vikara.among this amavata is most challenging to physician. To generate more study for management of amavata ,i have choose kala basti krama of dwipanchmooladi niruh and erand taila anuvasan in amavata basti is one of the such treatment which helps in breaking the basic samprapti of disease and giving relief in the symptoms .in amavata ,vata dosha is santarpan sadhya while ama is apatarpan sadhya . as these both opposite actions i treatment ,it is very diffcult to trat both ama and vata at the same time in amavata but basti itself is one of the prime tratement for vata dofha and vataj vyadhis as it acts on pakvashaya ,which is the moolasthan of vata. the study is divided into 2 arms with 32 participiants each. interventiom-kala basti krama of dwipanchmooladi niruh and erand taila anuvasan for 15days contol arm-vaitaran basti will be given for 7 days participiants will be selected as per inclusion criteria computred based randomazation process will be used. patient will be assessed on 0,16,24,32 day of study patients will be assessed as per subjective and objective criteria . |