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CTRI Number  CTRI/2025/06/089519 [Registered on: 25/06/2025] Trial Registered Prospectively
Last Modified On: 24/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical Trial to Evaluate Clinical Efficacy Of Laghupanchamoola Taila Matra Basti in Management Of Janusandhigata Vata(Knee joint pain)  
Scientific Title of Study   Randomized Clinical Trial To Evaluate Clinical Efficacy Of Laghupanchamoola Taila Matra Basti In Management Of Janusandhigata Vata 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abhilasha Pradip Akinwar  
Designation  M.D. Scholar 
Affiliation  Late kedari redekar college gadhinglaj  
Address  1st Floor Room no. 12 Dept of Panchkarma LKR Ayurvedic Mahavidyalaya Gadhinglaj
Midc Area Shendri Mal,A/p- Taluka Gadhinglaj District Kolhapur
Kolhapur
MAHARASHTRA
416501
India 
Phone  8999545850  
Fax  02327224988  
Email  abhilashaakinwar596@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Abhilasha Pradip Akinwar  
Designation  M.D. Scholar 
Affiliation  Late kedari redekar college gadhinglaj  
Address  1st Floor Room No.12 Dept of Panchkarma LKR Ayurvedic Mahavidyalaya Gadhinglaj
Midc Area Shendri Mal,A/p- Taluka Gadhinglaj District Kolhapur
Kolhapur
MAHARASHTRA
416501
India 
Phone  8999545850  
Fax  02327224988  
Email  abhilashaakinwar596@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sachin Patil 
Designation  Associate professor 
Affiliation  Late kedari Redekar Ayurvedic College Gadhinglaj 
Address  1st Floor Room no. 8 Dept. of Panchkarma LKR Ayurvedic College Gadhinglaj Kolhapur

Kolhapur
MAHARASHTRA
416501
India 
Phone  9823347244  
Fax  9823347244  
Email  drsachinayurved@gmail.com  
 
Source of Monetary or Material Support  
Lkr Ayurvedic Mahavidyalaya Gadhinglaj 416502 Dist-Kolhapur State-Maharashtra India  
 
Primary Sponsor  
Name  Abhilasha Pradip Akinwar  
Address  LKR Ayurvedic Mahavidyalaya Gadhinglaj Pincode-416502 Dist-Kolhapur State-Maharashtra India 
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 Abhilasha Pradip Akinwar  LKR Ayurvedic Mahavidyala Gadhinglaj  LKR Ayurvedic Mahavidyalaya Gadhinglaj 1st Floor Room no. 12 Dept. of Panchakarma Pin code -416501
Kolhapur
MAHARASHTRA 
8999545850

abhilashaakinwar596@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee LKR Ayurvedic College Gadhinglaj  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,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical
2Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Charak siddhisthan 4/53, Procedure details: Purva karma: The patients will be advised to consume little quantity of light diet before every Matrabasti. Before administering every Basti, local Abhyanga with lukewarm Tila taila will be done on abdomen, thighs, & buttocks for 5 to 10 minutes and after Abhyanga, the Nadi Swedana will be done on abdomen, thighs, and buttocks for 5 to 10 minutes. Pradhana Karma: The patient will be advised to lie down on left lateral position on Basti (enema) table with right lower extremity flexed on knee and hip joint and left lower extremity straight. The patient will be asked to keep his left hand below the head. Oil will be applied on anus with cotton dipped in oil. The 72 ml of lukewarm Laghupanchamoola taila will be filled in enema syringe. Rubber catheter oleated with oil will be attached to enema syringe and air will be removed. Rubber 15 | P a g e catheter will be introduced into anus of patient up to length of 4 inches. The taila will be pushed inside leaving little quantity within syringe in order to avoid entrance of vayu. While introduction of catheter and drug, the patient will be asked to take deep breath and not to shake his body. )
(1) Medicine Name: Laghu panchmool tail, Reference: charak chikitsa 28/138-139, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 7 Days
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  - Patient presenting with symptoms like Shoola in janusandhi, Shotha,
Prasaranajanya vedana, and Akunchanjanya vedana in janusandhi.
- Patients of age group between 40-70yrs irrespective of sex.
- Patients suffering from Knee Osteoarthritis.
- Both female and male sex. 
 
ExclusionCriteria 
Details  - Lactating mothers
- Pregnant women
- Patient suffering from Osteo tuberculosis
- Patient suffering from Osteo carcinoma
- Patient suffering from any metabolic disorders such as SLE,
Rheumatoid Arthritis
- Patient contraindicated for Swedan Karma 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Matra basti with laghupanchamoola taila is significantly effective in janusandhigata vata   On 0th 7th 14th 21th day of trial  
 
Secondary Outcome  
Outcome  TimePoints 
With the help of results obtained from study conclusion will be drawn  7 days 
Detailed study of matra basti with laghupanchamoola taila in janusandhigata vata.

To study in detail the literature of janusandhigata vata and its management from ayurvedic and modern text  
On 0th 7th 14th 21th day of trial  
Detailed study of matra basti with laghupanchamoola taila and janusandhigata vata
To study in detail the literature of janusandhigata vata and its management from ayurvedic and modern text  
On 0th 7th 14th 21th day of trial  
Matra basti with laghupanchamoola taila is significantly effective in janusandhigata vata   On 0th 7th 14th 21th day of trial  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 2/ Phase 3 
Date of First Enrollment (India)   01/08/2025 
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="0"
Months="1"
Days="6" 
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   Today’s in an era of modernization and civilization most of people have modern life style like consumption of junk food and less care about heath .

It causes vatiation of vata dosha , this vitiated vata dosha affects janusandhi of mainly old age people less than 40 years 

It is most commonly occuring and painful join disorder it makes it hard to do many activities every day .it is major cause of lost work time and serious disability for many people 

During the process of pathogenesis when vitiated vayu gets into the knee joint . Human being enable do work because due to impairement of function severe pain and swelling due to movement restricted 

Prasaranakunchana vedana is a classical symptoms of janusandhigata vata.vata dosha situated in janu sandhi and exibit symptoms like shotha shoola,vatapurnadushti sparsha and prasaranakunchana vedana.

In our classical ayurvedic test basti treatment is advised for vatiation of vata dosha .

Panchamoola is effective on vata dosha due to their laghu ruksha ushna virya and vata shamak property 
 
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