| CTRI Number |
CTRI/2024/06/068850 [Registered on: 13/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Ushnajalayukta Maadhutailika Vasti with Kvaathayukta Maadhutailika Vasti in the management of lowback ache |
|
Scientific Title of Study
|
Effectiveness of Ushnajalayukta Maadhutailika Vasti (UMV) in comparison with Kvaathayukta Maadhutailika Vasti (KMV) in Aaturahastapramana in the management of Kateegraha - A Pragmatic Randomized Controlled (Non-Inferiority) Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr LEEYA SAM |
| Designation |
PG Scholar |
| Affiliation |
Vaidyaratnam P S Varier Ayurveda College, Kottakkal |
| Address |
Department of Panchakarma
Vaidyaratnam P S Varier Ayurveda College Kottakkal
Malappuram
Kerala
676501
INDIA
Malappuram
KERALA
676501
India |
| Phone |
9207119349 |
| Fax |
|
| Email |
leeyasam98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SUBIN V R |
| Designation |
PROFESSOR |
| Affiliation |
Vaidyaratnam P S Varier Ayurveda College Kottakkal |
| Address |
Department of Panchakarma
Vaidyaratnam P S Varier Ayurveda College Kottakkal
Malappuram
Kerala
676501
India
Malappuram
KERALA
676501
India |
| Phone |
9961732125 |
| Fax |
|
| Email |
vaidyamadham.dr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SUBIN V R |
| Designation |
PROFESSOR |
| Affiliation |
Vaidyaratnam P S Varier Ayurveda College Kottakkal |
| Address |
Department of Panchakarma
Vaidyaratnam P S Varier Ayurveda College Kottakkal
Malappuram
Kerala
676501
India
Malappuram
KERALA
676501
India |
| Phone |
9961732125 |
| Fax |
|
| Email |
vaidyamadham.dr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vaidyaratnam P S Varier Ayurveda College Kottakkal
Edarikode P O
676501
Malappuram
Kerala
India |
|
|
Primary Sponsor
|
| Name |
Vaidyaratnam P S Varier Ayurveda College Kottakkal |
| Address |
Vaidyaratnam P S Varier Ayurveda College Kottakkal Edarikode P O
Malappuram Kerala 676501 |
| Type of Sponsor |
Other [AIDED COLLEGE] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr LEEYA SAM |
Vaidyaratnam P S Varier Ayurveda College Kottakkal |
OPD Department of Panchakarma
Room number A112
Malappuram
Kerala
Malappuram
KERALA |
9207119349
leeyasam98@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE VAIDYARATNAM P S VARIER AYURVEDA COLLEGE KOTTAKKAL |
Approved |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M489||Spondylopathy, unspecified. Ayurveda Condition: VATAVYADHIH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | mAdhutailikabastiH, माधà¥à¤¤à¥ˆà¤²à¤¿à¤•à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Harisaastri Paraadakar, editor. Ashtaaga Hrdayam composed by Vaagbhata with commentaries Sarvaangasundara and Aayurvedarasaayana. 10th edition. Varanasi: Chaukhamba orientalia, 2011. Kalpasiddhisthaana 4/27, 28; p.757, Procedure details: Poorvakarma - localized abhyanga with tila taila & nadi sweda.
Pradhana karma - kwathayuktha maadhutailika vasti on 2nd,4th and 6th day respectively.Anuvasana vasti with sahacharadi tailam 75 ml on remaining days.
Time of procedure - Niruha vasti : 10-11am, Anuvasana vasti - after lunch (12:30-1:30pm)
Dose - In standardized aaturahastapramana (240 ml)
Number of putaka - Till samyak niruha lakshana
Duration - 8 days )
(1) Medicine Name: Erandamoola kwatha,saindhava,madhu,shathahwa kalka,tila taila, Reference: Harisaastri Paraadakar, editor. Ashtaaga Hrdayam composed by Vaagbhata with commentaries Sarvaangasundara and Aayurvedarasaayana. 10th edition. Varanasi: Chaukhamba orientalia, 2011. Kalpasiddhisthaana 4/27, 28; p.757, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 240(ml), Frequency: od, Duration: 8 Days | | 2 | Intervention Arm | Procedure | - | mAdhutailikabastiH, माधà¥à¤¤à¥ˆà¤²à¤¿à¤•à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Agnivesa, Caraka Samhita, Jalpakalpatharu commentary by Gangadhara, C.K and Company limited. Kolkata, 1855, Sidhisthana 12/18; p.3806., Procedure details: Poorva karma - localized abhyanga with tila taila & nadi sweda.
Pradhana karma - Ushnajalayuktha maadhutailika vasti on the 2nd,4th & 6th day respectively. Anuvasana vasti with Sahacharadi taila 75ml on remaining days.
Time of procedure - Niruha vasti 10 - 11am Anuvasana vasti - After lunch (12:30 - 1:30) Duration - 8 days
Dose - In standardized aaturahastapramana (240ml)
Number of putaka - Till samyak niruha lakshana)
(1) Medicine Name: Ushnajala,madhu,saindhava,shatahwa,tila tailam, Reference: Agnivesa, Caraka Samhita, Jalpakalpatharu commentary by Gangadhara, C.K and Company limited. Kolkata, 1855, Sidhisthana 12/18; p.3806., Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 240(ml), Frequency: od, Duration: 8 Days |
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants eligible for vasti
Vyadhi avastha niraama
Participants who give informed consent |
|
| ExclusionCriteria |
| Details |
Known case of fracture or dislocation
Deformities or congenital defects
TB Spine
Known case of Neoplasam
Participants with uncontrolled Hypertension and Diabetes Mellitus
PREGNANT AND LACTATING WOMEN |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Samyak niruha lakshana
2.Event evaluation scale
3.Visual analogue scale
Oswestry disability index |
1.At base line
2.2nd,4th and 6th day
3.0th and 9th day
Oswestry disability index - 0th and 9th day |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
PHYSICO CHEMICAL CHARACTERISTICS
HPTLC |
At base line |
|
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Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/06/2024 |
| Date of Study Completion (India) |
25/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
A pragmatic randomized controlled (Non- Inferiority ) trial is planned to study the effectiveness of Ushnajalayukta Madhutailika Vasti (UMV) in comparison with Kvaathayukta Madhutailika Vasti (KMV) in Aaturahastapramana in the management of Kat’eegraha. 34 participants satisfying diagnostic and inclusion criteria will be taken for study. They will be allocated using computer generated block randomization into two groups (sequence concealed). Participants in both groups will be administered Maadhutailika Vasti in yoga–vasti pattern. Trial group will be administered Ushnajalayukta Madhutailika Vasti (UMV) in Aaturahastapramana and control group will be administered Kvaathayukta Maadhutailika Vasti (KMV) in Aaturahastapramana. Assessment will be done using Samyak niruha lakshana assessment proforma, Event evaluation scale, Visual Analogue Scale (VAS) and Oswestry Disability Index (ODI). Samyak niruha lakshana and Event evaluation scale will be assessed after each niruha in both groups. Other assessments will be done before treatment and after treatment. |