| CTRI Number |
CTRI/2025/07/090184 [Registered on: 04/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Aabhadi Choorna with Til Tail Abhyanga in Janu Sandhigata Vata |
|
Scientific Title of Study
|
Assesment of an add on effect of Aabhadi Choorna along with Tila Tail Abhyanga in Janu Sandhigata vata Randomized Controlled Trial |
| 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 Sanyogita Vikas Patil |
| Designation |
MD Scholar Kayachikitsa |
| Affiliation |
PMTS Ayurved College and Shri Eknath Rugnalaya Shevgoan |
| Address |
OPD NO 105 Kayachikitsa Department , Shri Eknath Ayurved Rugnalaya, PMTS Ayurved College Shevgoan,Akhegoan road ,TAL Shevgoan , DIST Ahilyanagar, MAHARASHTRA.
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
7218828509 |
| Fax |
|
| Email |
dr.sanyogitavpatil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Digvijay Zarekar |
| Designation |
Associate Professor |
| Affiliation |
PMTS Ayurved College and Shri Eknath Rugnalaya Shevgoan |
| Address |
OPD NO 105 Kayachikitsa Department , Shri Eknath Ayurved Rugnalaya, PMTS Ayurved College Shevgoan,Akhegoan road ,TAL Shevgoan , DIST Ahilyanagar, MAHARASHTRA.
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
9890908899 |
| Fax |
|
| Email |
digvijay.zarekar61@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Digvijay Zarekar |
| Designation |
Associate Professor |
| Affiliation |
PMTS Ayurved College and Shri Eknath Rugnalaya Shevgoan |
| Address |
OPD NO 105 Kayachikitsa Department , Shri Eknath Ayurved Rugnalaya, PMTS Ayurved College Shevgoan,Akhegoan road ,TAL Shevgoan , DIST Ahilyanagar, MAHARASHTRA.
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
9890908899 |
| Fax |
|
| Email |
digvijay.zarekar61@gmail.com |
|
|
Source of Monetary or Material Support
|
| PMTS Ayurved College and Shri Eknath Ayurved Rugnalaya,Shevgoan,Akhegoan road ,TAL Shevgoan , DIST Ahilyanagar, MAHARASHTRA,INDIA -414502 |
|
|
Primary Sponsor
|
| Name |
Dr Sanyogita Patil |
| Address |
PMTS Ayurved College and Shri Eknath Ayurved Rugnalaya,Shevgoan,Akhegoan road ,TAL Shevgoan , DIST Ahilyanagar, MAHARASHTRA,INDIA -414502 |
| 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 Sanyogita Vikas Patil |
PMTS Ayurved College and Shri Ekanth Rugnalaya , Shevgoan |
OPD NO 105 Kayachikitsa Department , Shri Eknath Ayurved Rugnalaya, PMTS Ayurved College Shevgoan,Akhegoan road ,TAL Shevgoan , DIST Ahilyanagar, MAHARASHTRA.
Ahmadnagar
MAHARASHTRA |
07218828509
dr.sanyogitavpatil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PMTs Ayurved College, Shevgoan Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M17||Osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | aBya~ggaH, अभ्यंग | (Procedure Reference: Charak Sutrasthana 13/12 and Sushrut Chikitsasthana24/30 Dalhana Tika, Procedure details: The verse given states that massaging body / body parts with Til Tail provides Baal which means Power.
Simple Rotatary Movement over Knee joint advised for 15 minutes reaches to Asthi.)
(1) Medicine Name: Til Tail, Reference: Charak Sutrasthana 27/286-288, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 28 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Aabhadi Choorna, Reference: Yog Ratnakar Vaat Vyadhiadhikar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Ushnodak), Additional Information: Add on with Til Tail Abhyanga over Janu Sandhi with Rotatary Movement for 15 minutes | | 3 | Comparator Arm | Procedure | - | aBya~ggaH, अभ्यंग | (Procedure Reference: Charak Sutrasthana 13/12 and Sushrut Chikitsasthana24/30 Dalhana Tika, Procedure details: The verse given states that massaging body / body parts with Til Tail provides Baal which means Power.
Simple Rotatary Movement over Knee joint advised for 15 minutes reaches to Asthi.)
(1) Medicine Name: Til Tail, Reference: Charak Sutrasthana 27/286-288, , Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Duration: 28 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.The patients presenting with the signs and symptoms of Janu sandhigata vata – Sandhi shoola , Sandhi shotha , Sandhi Atopa , Akcunchana Prasarana Vedana .
2.Patients in the age group from 40 to 55 years will be selected.
3.Patients will be selected irresepective of Gender, Religion and Economic status.
4.Patient who gives written consent.
|
|
| ExclusionCriteria |
| Details |
1.Patients suffering from K/C/O - Rheumatoid arthritis, Rheumatic fever, Rheumatic Heart disease, Gouty arthritis, Ankolysing Spondolysis and Psoriatic arthritis.
2.Patients Suffering from Aamvata , Vatarakta , Kroshtukshirsha ,Asthi – Majjagata Vata , Sarvangavata .
3.Patient suffering with infective K/C/O – Supparative arthritis , HIV , HbsAg.
4.Patient undergoing Steroid Thearpy .
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Aabhadi Choorna with Til Tail Abhyanga and Til Tail alone in Janu Sandhigata Vata. |
Twice a Day after meal for 28 days with 5 follow ups on 0th , 7th ,14th,21st and 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To Review the Literature about drugs of Aabhadi churna and Tila tail from various Samhitas
2.To review the literature about Sandhigata vata and Osteoarthritis from various Books
3.To Evaluate the efficacy of Aabhadi Churna along with Tila Tail in Janu Sandhigata vata
4.To Evaluate efficacy of Tila Tail Abhyanga alone in Janu Sandhigata Vata
5.To Observe Any Adverse Effect of Drug / Procedure if occurs.
|
Twice a Day after meal for 28 days with 5 follow ups on 0th , 7th ,14th,21st and 28th day |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
04/08/2025 |
| 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="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 degenerative disorder,
caused by breakdown of cartilage and underlying bone. Osteoarthritis is the
second most common rheumatologic problem in India. It is the most frequent
joint disease with a prevalence of 22 percent to 39 percent in India.OA is more common in
women than men, but the prevalence increases dramatically with age. Nearly, 45 percent of women over the age of 65 years have symptoms while radiological evidence is
found in 70 percent of those over 65 years.OA of the knee is a major cause of mobility
impairment, particularly among females.OA was estimated to be the 10th leading
cause of nonfatal burden. The
modern science can touch this disease in a conservative way with help of
Corticosteriods, NSAIDs, Narcotics and Opoids which causes a temporary sense of
pain relief and no pathological reversal with a list of adverse effects. Hence,
there is no exact relief from the modern management.
While
the Ayurveda has shown a lot of great possible outcomes in the managing the
pain and other symptoms and underlying pathology without much intervention. In
Ayurvedic Textbooks, there is detailed description of Sandhigata vata
and its management which includes Snehana, Swedana, Agnikarma, Upanaha, Unmardan
, Bandhana.
The
treatment is effective with no adverse effects; We are attempting to evaluate
the efficacy of Aabhadi Choorna with Tila Taila Abhyanga which can
breakdown the pathology of Sandhigata Vata. Churna is extensively described in all Samhitas. It is noticed that the
use of Choorna Kalpana is getting increased along with the advancing
period.As it can be taken with many Anupanas , a
consideration for any Anupanas according to requirement can be done
easily which increases the pallatibility .It does have shelf life of 2 months .Churnas are used to make Vati, Avaleha, Arka, Kasaya, Hima, Phanta, Snehas
which is the main content, this gives it a prime importance. The Abhyanga is a procedure that can be
performed on daily basis (abhyanga acharen nitya ) .In
case of Janu Sandhigat Vata ,Abhyanga with taila is done with rotatory movements over knee
joint . Abhyanga is termed to be one of the important Upakrama for
Vata Dosha Shamana.Abhyanga is not an invasive method .It is cost effect
with good mode of action as it keeps ability to go in sukshma marga and
cure the disease .It helps in reducing the symptoms as well as underlying
pathogenesis.
This
treatment helps to improve the quality of life and provide free mobility of
joints with pain relief. So to upgrade the existing knowledge gap we
concluded to work over this topic. |