| CTRI Number |
CTRI/2025/03/081633 [Registered on: 04/03/2025] Trial Registered Prospectively |
| Last Modified On: |
28/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison on the effectiveness of increased dosage and fixed dosage of Matra basti with Karaskara ghrita in Janu sandhighata vata - Osteoarthritis of knee joint |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY ON THE EFFICACY OF AROHANA KRAMA AND SADHARANA KRAMA MATRA BASTI WITH KARASKARA GHRITA IN THE MANAGEMENT OF JANU SANDHIGATA VATA-OSTEOARTHRITIS OF KNEE JOINT |
| 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 Akshara K Narayanan |
| Designation |
2 nd year PG scholar |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda College and Hospital |
| Address |
Department of Panchakarma Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital OPD 26 Anchepalya Bengaluru
Bangalore
KARNATAKA
560074
India |
| Phone |
8590164587 |
| Fax |
|
| Email |
aksharaanuvinda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitin V |
| Designation |
Assistant professor |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital |
| Address |
Department of Panchakarma Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital OPD 26 Anchepalya Bengaluru
Bangalore
KARNATAKA
560074
India |
| Phone |
9901865656 |
| Fax |
|
| Email |
dr.nitin.v.89@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitin V |
| Designation |
Assistant professor |
| Affiliation |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital |
| Address |
Department of Panchakarma Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital OPD 26 Anchepalya Bengaluru
KARNATAKA
560074
India |
| Phone |
9901865656 |
| Fax |
|
| Email |
dr.nitin.v.89@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthala Manjunatheshwara
Institute of Ayurveda College and Hospital Banglore -560074 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Dr Akshara K Narayanan |
| Address |
Department of Panchakarma OPD 26 Shri Dharmasthala Manjunatheshwara
Institute of Ayurveda and Hospital Anchepalya
Bengaluru Karnataka 560074 India |
| Type of Sponsor |
Other [(Self)] |
|
|
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 Akshara K Narayanan |
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital |
Department of Panchakarma Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital OPD 26 Anchepalya
Bangalore
KARNATAKA |
8590164587
aksharaanuvinda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:7||Osteopathic. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Karaskara Ghrita, Reference: Sahasrayogam ghrita prakara, Route: Rectal, Dosage Form: Ghrita, Dose: 72(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 9 Days, anupAna/sahapAna: No, Additional Information: 1st day - 24ml, 2nd - 30ml, 3rd - 36ml, 4th - 42ml, 5th - 48ml, 6th - 54ml, 7th - 60ml, 8th - 66ml, 9th - 72ml | | 2 | Intervention Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: sharangadhara uttara khanda chapter 5/5, Procedure details: PURVA KARMA:
It includes collection of the material, examination of the patient, preparation of the patient, diet before the procedure & preparation of the medicne.
PRADANA KARMA:
• Tip of the Vasti netra should be smeared with sneha dravya for easy administration.Air inside the Vasti yantra to be removed by squeezing the Vasti putaka.Tip of the vasti netra closed with index finger, Vasti netra inserted in to the anal aperture till the first karnika along the direction of vertebral column.Vasti putaka is squeezed with moderate pressure & little residue left as such in the putaka to prevent the entry of air. Withdraw the Vasti netra without causing any injury to the surrounding areas.
•PASCHAT KARMA:
•After the aministration of enema, patient should lie on supine position beaten on his buttocks with hands & his heels. Foot end of the cot should be raised thrice. He should be made to lie down on a pillow with body extended. Palms & soles should be massaged. Massage in anticlockwise direction is advised over the abdomen. If patient complaints of any bodyache, an unctuous massage with pressure to be given. By doing all these measures, early expulsion of sneha dravya can be prevented. Patient is instructed to lie down in supine for a minimum of hundred matra kala.
When there is urge for defecation he should attend the same. If there is immediate expulsion of snehadravya, one more Vasti can be given. Patient is instructed to take very light diet unless he feels hunger.Maximum retention time of sneha dravya in Sneha Vasti is 3 yama’s (9 hours).There may be possibility of absorption of sneha dravya in rooksha persons.)
| | 3 | Comparator Arm | Procedure | - | mAtrAbastiH, मात्राबस्तिः | (Procedure Reference: charaka chikita sthana chapter 28/37, Procedure details: PURVA KARMA:
It includes collection of the material, examination of the patient, preparation of the patient, diet before the procedure & preparation of the medicne.
PRADANA KARMA:
•Tip of the Vasti netra should be smeared with sneha dravya for easy administration.Air inside the Vasti yantra to be removed by squeezing the Vasti putaka.Tip of the vasti netra closed with index finger, Vasti netra inserted in to the anal aperture till the first karnika along the direction of vertebral column.Vasti putaka is squeezed with moderate pressure & little residue left as such in the putaka to prevent the entry of air. Withdraw the Vasti netra without causing any injury to the surrounding areas.
•PASCHAT KARMA:
•After the aministration of enema, patient should lie on supine position beaten on his buttocks with hands & his heels. Foot end of the cot should be raised thrice. He should be made to lie down on a pillow with body extended. Palms & soles should be massaged. Massage in anticlockwise direction is advised over the abdomen. If patient complaints of any bodyache, an unctuous massage with pressure to be given. By doing all these measures, early expulsion of sneha dravya can be prevented. Patient is instructed to lie down in supine for a minimum of hundred matra kala.
When there is urge for defecation he should attend the same. If there is immediate expulsion of snehadravya, one more Vasti can be given. Patient is instructed to take very light diet unless he feels hunger.Maximum retention time of sneha dravya in Sneha Vasti is 3 yama’s (9 hours).There may be possibility of absorption of sneha dravya in rooksha persons.)
| | 4 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Karaskara Ghrita, Reference: Sahasrayogam ghrita prakarana, Route: Rectal, Dosage Form: Ghrita, Dose: 72(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 9 Days, anupAna/sahapAna: No, Additional Information: Fixed dosage 72 ml ever day |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with signs and symptoms of janusandhigatavata
2. Patient fit for Matrabasti karma
3. Patient between the age group of 40 and 70 years
4. No discrimination of gender and chronicity
|
|
| ExclusionCriteria |
| Details |
1. Patient below 40 and above 70 years are excluded
2.Systemic diseases like Uncontrolled Diabetes, Uncontrolled Hypertension, Carcinoma, Tuberculosis,Fractured knee.
3. Patient having Ama laksha
4. Patient suffering with Arsha, gudabhramsha, parikartika. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Improvement in Range of motion measured by Goniometry.
2.Reduction of pain is measured by using VAS(Visual Analog Scale).
3.Reduction in the Swelling is measured by using Measurement tape. |
0th day (before treatment - 1st assessment) 10th day (after treatment - 2nd assessment)
FOLLOW UP-1st Follow up on 28thday( Final assessment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in the quality of life by reducing the pain, dependency and improving the functionality related to knee joint.(WOMAC questionnaire). |
0th day (before treatment - 1st assessment) 10th day (after treatment - 2nd assessment)
FOLLOW UP-1st Follow up on 28thday( Final assessment) |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
11/03/2025 |
| 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="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 a prevalent degenerative joint disease characterized by
pain,swelling and stiffness,affecting a person’s ability to move freely .In 2019 WHO
mentions about 528 million people worldwide suffered from Osteoarthritis that
is almost 113% increase since 1990 and it is still increasing in present era. It commonly affects weight-bearing
joints such as the knees, hips, and spine. While it can occur at any age, it’s
more common in older adults due to wear and tear over time. Symptoms often
worsen over time, impacting daily activities and quality of life.
Janu
Sandhigata Vata
is primarily caused by an imbalance of Vata dosha, the principle of
movement and change in the body. Matravasti is an effective therapy for
pacifying Vata dosha by restoring balance to Vata dosha. The medicated oils used in Matravasti are specifically chosen for their
ability to nourish and strengthen the tissues of the knee joint. By nourishing
the joint tissues, Matravasti supports the repair and
regeneration of damaged cartilage and other structures affected by Janu
Sandhigata Vata.As Sandhigata Vata is Asthi asrita vyadhi
in which Acharya Susrutha have mentioned the use of Snehana ie,both Bahya
and Abhyantara,as Matravasti is one among sneha basti and
can be administered in all age groups without any restrictions in any climatic
condition it can be considered as the best management principle in treating Janu
Sandhigata Vata.Karaskara Ghrita relieves pain and swelling in
inflammatory disorders. It heals and nourishes the degenerative joints
mentioned in Sahasrayogam. In this study Matravasti is
administered in two different methods ie,Arohana krama(increasing order)
mentioned in Adhamalla’s commentry on Sharangathara Samhita and Sadharana
krama(fixed dose). Hence
an attempt is made to evaluate the effect of Matravasti in Arohana and Sadharana krama in Janusandhigata Vata patients. |