| CTRI Number |
CTRI/2024/10/075183 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
13/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study OF Matra Basti and Nasya Karma with Dashamoola Taila in the management of Avabahuka W.S.R to Frozen Shoulder. |
|
Scientific Title of Study
|
A Randomized comparative clinical study of Matra Basti and Nasya Karma With Dashamoola Taila in the management of Avabahuka W.S.R to Frozen Shoulder. |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepa Patil |
| Designation |
PG SCHOLAR |
| Affiliation |
SSRAMC,Inchal |
| Address |
Dept of PG Studies in Panchakarma. Shri Shivayogeeshwar Rural Ayurvedic Medical college,Hospital and Post graduate Research Centre Inchal.
Dept of PG Studies in Panchakarma. Shri Shivayogeeshwar Rural Ayurvedic Medical college,Hospital and Post graduate Research Centre Inchal. Tq - Savadatti
Belgaum
KARNATAKA
591102
India |
| Phone |
07259324349 |
| Fax |
7259324349 |
| Email |
deepabpatil75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C R Pujar |
| Designation |
Professor |
| Affiliation |
SSRAMC,Inchal |
| Address |
Dept of PG Studies in Panchakarma. Shri Shivayogeeshwar Rural Ayurvedic Medical college,Hospital and Post graduate Research Centre Inchal.
Dept of PG Studies in Panchakarma. Shri Shivayogeeshwar Rural Ayurvedic Medical college,Hospital and Post graduate Research Centre Inchal. Tq - Savadatti
Belgaum
KARNATAKA
591102
India |
| Phone |
9743438241 |
| Fax |
9743438241 |
| Email |
drchannupujar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepa Patil |
| Designation |
PG SCHOLAR |
| Affiliation |
SSRAMC,Inchal |
| Address |
Dept of PG Studies in Panchakarma. Shri Shivayogeeshwar Rural Ayurvedic Medical college,Hospital and Post graduate Research Centre Inchal.
Dept of PG Studies in Panchakarma. Shri Shivayogeeshwar Rural Ayurvedic Medical college,Hospital and Post graduate Research Centre Inchal. Tq - Savadatti
Belgaum
KARNATAKA
591102
India |
| Phone |
07259324349 |
| Fax |
7259324349 |
| Email |
deepabpatil75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Shivayogeeshwar Rural Ayurvedic Medical College, Hospital and Post Graduate Research Centre Inchal. Tq - Savadatti, Dist - Belgaum, State - Karnataka.
Pin Code - 591102 |
|
|
Primary Sponsor
|
| Name |
Dr Deepa Patil |
| Address |
Department Of Panchakarma,SSRAM college, Inchal.Dist-Belgaum,State-Karnataka
Pin code-591102 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Deepa Patil |
Shri Shivayogeeshwar Rural Ayurvedic Medical college,Hospital and Post graduate Research Centre |
Department of PG Studies in Panchakarma, Shri Shivayogeeshwar Rural Ayurvedic Medical College Inchal.
Belgaum
KARNATAKA |
7259324349
7259324349
deepabpatil75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee S.S.R.Ayurvedic Medical College and Hospital, Inchal |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M959||Acquired deformity of musculoskeletal system, unspecified. Ayurveda Condition: AVABAHUKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | Matra Basti | (Procedure Reference: Charak Samhita, Sushrut Samhita, Ashtanga Hrudaya, Sharangdhar Samhita, Procedure details: Matra Basti is a type of Sneha Basti in which less quantity of Sneha is administered irrespective of seasons & does not produce any coplication.
Duration - 7 days
Dose -72ml)
(1) Medicine Name: Dashamoola Taila, Reference: Bheshaajya Ratnavali, Shiroroga Chikitsa, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | Nasya | (Procedure Reference: Charak Samhita, Sushrut Samhita, Ashtang Sangraha, Procedure details: Nasya Karma is a theraoeutic measure where the medicated oil, Kvatha, Swarasa, Churna are administered through Nose, After following purvakarma like Snehana & Swedana to eliminate the vitiated Dosha situated in sira for the treatment of Urdhvajatrugata Vikaras.
Duration - 7 days
Dose - 8 drops each Nostril)
(1) Medicine Name: Dashamoola Taila, Reference: Bheshaajya Ratnavali, Shiroroga Chikitsa, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days | | 3 | Intervention Arm | Procedure | - | Matra Basti | (Procedure Reference: Charak samhita, Sushrut Samhita, Ashtanga Hrudaya, Sharangdhar samhita, Procedure details: Matra Basti is a type of sneha Basti in which less quantity of sneha is administered irrespective of seasons & does not produce any complication)
(1) Medicine Name: Dashamoola Taila, Reference: Bheshaajya Ratnavali, Route: Rectal, Dosage Form: Taila, Dose: 72(ml), Frequency: od, Duration: 7 Days | | 4 | Intervention Arm | Procedure | - | Nasya | (Procedure Reference: Charak Samhita, Sushrut Samhita, Ashtang Sangraha, Procedure details: Nasya Karma is therapeautic measure where the medicated oil, Kvatha, Swarasa, Churna are administered through Nose, After following Purvakarma like Snehana & Swedana to eliminate the vitiated Dosha Situated in Sira for the treatment of Urdhajatrugata Vikaras)
(1) Medicine Name: Dashamoola Taila, Reference: Bheshaajya Ratnavali, Route: Nasal, Dosage Form: Taila, Dose: 8(drops), Frequency: od, Duration: 7 Days |
|
|
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Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with either sex between the age group 16 to 60 yrs with Bahu praspanditahara, Amsa sandi shoola, Amsa shosha, Stambha are selected. |
|
| ExclusionCriteria |
| Details |
Patient unfit for basti and Nasya karma, with history of fracture and dislocation, below 16 yrs and above 60 yrs, with systemic illness, pregnant and lactating mother. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Bahu praspanditahara, Amsa sandi shoola is reduced, Amsa shosha is reduced, Stambha is reduced with Dashamoola Taila |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Bahu praspanditahara, Amsa sandi shoola, Amsa shosha,Stambha |
After 7 days treatment |
|
|
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 |
|
Date of First Enrollment (India)
|
24/10/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/10/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="28" |
|
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
|
A RANDOMIZED COMPARATIVE CLINICAL STUDY OF MATRA BASTI AND NASYA KARMA WITH DASHAMOOLA TAILA IN THE MANAGEMENT OF AVABAHUKA W.S.R. TO FROZEN SHOULDER.
OBJECTIVES OF THE STUDY : a) To study the effect of Matra Basti in Avabahuka with Dashamoola taila. b) To Study the effect of Nasya Karma in Avabahuka with Dashamoola taila. c) To Study and compare the effect of Matra Basti and Nasya Karma in Avabahuka with Dashamoola Taila.
METHODS AND MATERIALS :
SOURCE OF DATA a) Literary Source - Ayurvedic classics and textbooks Modern Medical books Articles published from journals and Magazines Related data Source from Website
b) Clinical Source - Patient of either sex attending OPD and IPD department of Panchakarma of S.S.R.A.M College and Hospital Inchal, Belagavi, Karnataka
c) Drug Source - All the drugs are collected from local areas, market and medicine will be prepared in S.S.R.A.M Pharmacy Inchal as per classics.
METHODS OF COLLECTION OF DATA :
A special proforma will be prepared with all points of History taking, Physical signs and Symptoms as mentioned in Ayurveda and accordingly. Selected patients will be subjected to detailed clinical history and complete physical examination.
A) DESIGN OF THE STUDY (INTERVENTION) :
It is a randomized comparative clinical study. The patients will be selected irrespective of sex, caste, race based on the diagnostic inclusion and exclusion criteria.
The selected patients will be randomly grouped into two groups of 20 each. After intervention the results obtained will be statistically analyzed.
GROUP A - 20 Patients will be administered Matra Basti. GROUP B - 20 Patients will be administered Nasya Karma. Treatment duration - 7 days Total duration of study - 15 days
Assessment will be done on - Before treatment and 7th day Follow up will be done on - 15th day
B) DIAGNOSTIC CRITERIA : Bahu Praspanditahara Amsa sandi shoola Amsa shosha Stamba X-ray
a) Inclusion criteria : Patient fit for Basti and Nasya Karma Patient of either sex Patient with clinical feature of Avabahuka Age group 16-60yrs
b) Exclusion criteria : Patient unfit for basti and Nasya karma Patient with history of fracture and dislocation Patient below 16yrs and above 60yrs Patient with systemic illness Pregnant and lactating mother
PARAMETERS OF STUDY :
a) Subjective parameters : Bahu Praspanditahara Amsa Sandi Shoola Stambha Amsa Shosha
b) Objective parameters : Swelling Tenderness Sandi Graham (Goniometer reading) : Forward flexion Hyper extention Abduction Internal rotation External rotation
INVESTIGATION : CBC RBS X-Ray of affected Sandhi
ASSESSMENT CRIETERIA : A detailed profoma will be prepared for the assessment of subjective and objective parameters by grading them. The data obtained will be analyzed statistically with suitable method.
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