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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Comparator Arm | Drug | Classical | | | 2 | Intervention Arm | Procedure | - | 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 |