| CTRI Number |
CTRI/2025/03/082489 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparison of the effect of multiple administration of Gandharvahastadi rooksha Vasti and single administration of Gandharvahastadi Rooksha Vasti in management of low back pain |
|
Scientific Title of Study
|
Effectiveness of Multiple putaka gandharvahastadi rooksha vasti (MGR) in comparison with Single putaka gandharvahastadi rooksha vasti (SGR) on samyak rooksha lakshana and samyak nirooha lakshana in kateegraha
:- A Pragmatic randomised 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 Mithun Prabhakar R |
| Designation |
PG scholar |
| Affiliation |
VPSV Ayurveda College |
| Address |
Department of panchakarma VPSV Ayurveda college Kottakkal
Malappuram
Malappuram
KERALA
676501
India |
| Phone |
9562283878 |
| Fax |
|
| Email |
rmpayurveda8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subin V R |
| Designation |
Professor |
| Affiliation |
VPSV Ayurveda College |
| Address |
Department of panchakarma VPSV Ayurveda college Kottakkal
Malappuram
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 |
VPSV Ayurveda College |
| Address |
Department of panchakarma VPSV Ayurveda college Kottakkal
Malappuram
KERALA
676501
India |
| Phone |
9961732125 |
| Fax |
|
| Email |
vaidyamadham.dr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vaidhyaratnam P S Varrier Ayurveda College Kottakkal
Malappuram Kerala
PIN Code :- 676501 |
|
|
Primary Sponsor
|
| Name |
VPSV Ayurveda College Kottakkal |
| Address |
VPSV Ayurveda College Kottakkal Edarikkode(P.O)Malappuram Kerala 676501 |
| Type of Sponsor |
Other [Aided 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 Mithun Prabhakar R |
VPSV Ayurveda College Hospital Kottakal |
OPD Department of Panchakarma
Room No A112
kottakkal
Malappuram
KERALA |
9562283878
rmpayurveda8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee [IEC] 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:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: 4. Ram Karan Sharma & Vaidya Bhagwan Dash, editor. Charaka samhitha of Agnivesha text with English translation & critical exposition based on Chakrpaniduttass Ayurveda Dipika. 10th edition: Chaukhambha Surbharati Prakashan; 2009 sidhi stana 10/16–17 commentary. p.371, Procedure details: Poorva Karma (Pre-procedure) :- The patient is first educated about the procedure, & informed consent is obtained. Before administration, the patient is advised to satisfy natural urges, & vitals are checked. A light breakfast is recommended between 7:30 & 8:00 A.M. The preparation of medicine begins with cleaning & drying the mortar & pestle, followed by mixing Vaishwanara choorna (30g) with Gandharvahastaadi kashaya (300ml) in a clockwise direction. The mixture is then filtered through a fine cotton cloth, warmed to 38-39ºC using steam, & kept aside for administration by 10:30 A.M.
Pradhana Karma (Main Procedure):-The patient undergoes bashpa sweda (steam fomentation) on the abdomen & lower back before positioning on a 15º slanting table with the head at the lower end. The patient is placed in the left lateral position with the left leg extended & the right leg flexed at the hip & knee. Wearing surgical gloves, the practitioner prepares the vasti instrument by closing the sterile vasti netra tip with a cotton wick, filling the vasti puṭaka with the warm medicine, & securing it properly. After lubricating the vasti netra & anal verge with oil, air is released from the instrument before insertion. The patient is instructed to exhale through the mouth while the vasti netra is gently inserted parallel to the vertebral column up to the first karnika. The medicine is then steadily administered by squeezing the vasti puṭaka. After administration, the vasti netra is carefully withdrawn, & the time is noted.
Paschat Karma (Post-procedure):- The patient is asked to lie in a supine position with a pillow under the head & to evacuate the bowel upon feeling the urge. The retention time is noted, & the patient is advised not to lock the toilet door. Observations on the contents of vega (evacuation) & the assessment of bala & samyak nirooha lakshana are recorded. After complete evacuation, the patient should bathe with hot water & apply rasnadi choorna on the head after drying with a towel. Immediate food intake is advised, along with dietary & lifestyle recommendations (pathya-apathya).
)
| | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: T Sreekumar. Ashtanga hrudhaya sutrasthana . Dr. N. Shandi, editor. Vol. 2. mannuthy: harisree hospital; 2016. chap 19,sloka 47-48.p.92, Procedure details: Poorva Karma (Pre-procedure) :-The patient is first educated about the procedure, & informed consent is obtained. Before administration, the patient is advised to satisfy natural urges, & vitals are checked. A light breakfast is recommended between 7:30 & 8:00 A.M. The preparation of medicine begins with cleaning & drying the mortar & pestle, followed by mixing Vaishwanara choorna (30g) with Gandharvahastaadi kashaya (300ml) in a clockwise direction. The mixture is then filtered through a fine cotton cloth, warmed to 38-39ºC using steam, & kept aside for administration by 10:30 A.M.
Pradhana Karma (Main Procedure):-The patient undergoes bashpa sweda (steam fomentation) on the abdomen & lower back before positioning on a 15º slanting table with the head at the lower end. The patient is placed in the left lateral position with the left leg extended & the right leg flexed at the hip & knee. Wearing surgical gloves, the practitioner prepares the vasti instrument by closing the sterile vasti netra tip with a cotton wick, filling the vasti puṭaka with the warm medicine, & securing it properly. After lubricating the vasti netra & anal verge with oil, air is released from the instrument before insertion. The patient is instructed to exhale through the mouth while the vasti netra is gently inserted parallel to the vertebral column up to the first karnika. The medicine is then steadily administered by squeezing the vasti puṭaka. After administration, the vasti netra is carefully withdrawn, & the time is noted.
Paschat Karma (Post-procedure):-The patient is asked to lie in a supine position with a pillow under the head & to evacuate the bowel upon feeling the urge. The retention time is noted, & the patient is advised not to lock the toilet door. Observations on the contents of vega & the assessment of bala & samyak nirooha lakshana are recorded. After complete evacuation, the patient should bathe with hot water & apply rasnadi choorna on the head after drying with a towel. Immediate food intake is advised, along with dietary & lifestyle recommendations (pathya-apathya). If multiple puṭaka administration is required, the assessment of samyak nirooha lakshana & bala is done after the evacuation of each puṭaka using appropriate scales. If the patient has adequate bala but has not attained samyak nirooha lakshana, the next puṭaka is administered immediately. The assessment is repeated after each evacuation, & if the criteria are still unmet, another puṭaka is given. This process can be continued up to a maximum of four puṭaka, considering the highest permissible dose of vasti, which is 12 prasrutha.
)
|
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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
Participants who have bala after first putaka
Presence of Aama Avastha on aama assessment scale
Patients who falls in severe and moderate categories as per Oswestry Disability Index for Low Back Pain
Participants giving informed consent
|
|
| ExclusionCriteria |
| Details |
Participants with Known case of fracture or dislocation of vertebrae
Participants with TB spine
Participants with Deformities or congenital defects
Participants with Known case of uncontrolled hypertension and Diabetes mellitus
Participants with Known case of neoplasm
Participants with Known case of renal disorders
Participants with Pregnant and lactating women
Participants with Known case of Haemorrhoids |
|
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Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Samyak nirūha lakṣaṇa Assessment
Samyak rūkṣa lakṣaṇa Assessment
|
every day after administration of each puá¹aka of vasti
On evening of each day of vasti
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Visual Analogue Scale
Oswestry Disability Index |
On evening of each day of vasti
before treatment and last day of vasti |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
27/03/2025 |
| 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 Yet Recruiting |
| 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 pragmatic randomized controlled trial is planned to study
the effectiveness of Multiple putaka rooksha
vasti (MGR) in comparison with Single putaka rooksha vasti (SGR) on Samyak rooksha
lakshana and Samyak nirooha lakshana in Katigraha. A total of 42 participants
satisfying the diagnostic criteria will be included in the study and allocated
into two groups using computer-generated block randomization (sequence
concealed). Participants in the trial group will receive Multiple putaka
Gandharvahastaadi rooksha vasti (MGR) for a maximum of three days until they
attain Samyak rooksha lakshana, whereas participants in the control group will
be administered Single putaka Gandharvahastaadi rooksha vasti (SGR) for a
maximum of seven days until they attain Samyak rooksha lakshana. Assessments
will be conducted using Samyak nirooha lakshana and Samyak rooksha lakshana assessment
proforma, Visual Analogue Scale, and Oswestry Disability Index. Additionally,
the Event Evaluation Scale for rooksha lakshana and nirooha lakshana will be
assessed after each putaka in both groups, while other assessments will be
conducted before and after treatment in each group.
|