| CTRI Number |
CTRI/2022/12/048246 [Registered on: 19/12/2022] Trial Registered Prospectively |
| Last Modified On: |
16/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
To study the effect of Kati Basti & Matrabasti in Gridhrasi |
|
Scientific Title of Study
|
A Comparative Randomised Open Label Clinical study of Kati Basti & Matrabasti with Kubj Prasarani taila in the management of Gridhrasi wsr to Sciatica |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parul Gautam |
| Designation |
PG Scholar |
| Affiliation |
Shubhdeep Ayurved Medical College and Hospital |
| Address |
Post Graduate Department of Panchkarma,shubhdeep Ayurved Medical College and Hospital,village-Datoda,Khandwa road,Indore(M.P.)
Indore
MADHYA PRADESH
452020
India |
| Phone |
7024896167 |
| Fax |
|
| Email |
parulgautam50@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monika Das |
| Designation |
Reader |
| Affiliation |
Shubhdeep Ayurved Medical College |
| Address |
Post Graduate Department of Panchkarma,shubhdeep Ayurved Medical College and Hospital,village-Datoda,Khandwa road,Indore(M.P.)
Indore
MADHYA PRADESH
452020
India |
| Phone |
9425320769 |
| Fax |
|
| Email |
dasmonika16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monika Das |
| Designation |
Reader |
| Affiliation |
Shubhdeep Ayurved Medical College |
| Address |
Post Graduate Department of Panchkarma,shubhdeep Ayurved Medical College and Hospital,village-Datoda,Khandwa road,Indore(M.P.)
Indore
MADHYA PRADESH
452020
India |
| Phone |
9425320769 |
| Fax |
|
| Email |
dasmonika16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shubhdeep Ayurved Medical College and Hospital Indore Madhya Pradesh |
|
|
Primary Sponsor
|
| Name |
Shubhdeep Ayurved Medical College and Hospital |
| Address |
Department of Panchkarma Shubhdeep Ayurved Medical College and Hospital Village-Datoda,Khandwa road,Indore -452020(M.P.),India |
| 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 Parul Gautam |
Shubhdeep Ayurved Medical College and Hospital |
Department of Panchkarma Shubhdeep Ayurved Medical College and Hospital,village-Datoda,Khandwa Road,Indore (M.P.)452020
Indore
MADHYA PRADESH |
07024896167
parulgautam50@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical Committee,Shubhdeep Ayurved medical college and hospital,indore |
Approved |
|
|
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: Gridhrasi, (2) ICD-10 Condition:G544||Lumbosacral root disorders, not elsewhere classified. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: charak chikitsa sthan 28/104, Procedure details: • Poorvakarma :Abhyang with Murchit Tila Taila & Nadi sweda will be done.
• Pradhan Karma :Matra basti of Kubj Prasarni taila 30 ml after breakfast for 7 days.
• PaschatKarma : Lie in supine position for 15 min. & avoid day sleep.
)
(1) Medicine Name: kubj prasarni taila, Reference: chakradutta vata vyadhi chikitsa 22/210-214, Route: Rectal, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | kaTibastiH, कटिबसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: charak chikitsa sthan 28/104, Procedure details: • PoorvaKarma :Preperation of mash pishti & Sthanik Abhyang with murchit tila taila mradu swedan .
• Pradhan Karma :Kati basti with Kubj Prasarni Taila ( 45 min.) for 7 days.
• PaschatKarma : 1.Area will be wiped off & cleanse properly.
2. Patient is advised to rest for 1 hour later to take hot water bath.
)
(1) Medicine Name: kubj prasarni taila, Reference: chakradutta vata vyadhi chikitsa 22/210-214, Route: Topical, Dosage Form: Taila, Dose: 200(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
• Diagnosed case of Gridhrasi with symptoms.
• Patient willing to participate in clinical trial (Consent duly filled ).
• Patients aged between 20-70 years with irrespective of gender & fit for Basti Karma.
|
|
| ExclusionCriteria |
| Details |
• Patients having any kind of anomalies (anatomical / congenital) & need surgical assessment.
• Patients not willing for clinical trial.
• Patient who are suffering from Tuberculosis of spine, carcinoma of spine any kind of tumor, uncontrolled diabetes mellitus , known pregnancy etc.
• Patient above 70 years.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| significant relief in pain in the patients of gridhrasi |
At baseline day and after completion of trial |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| significant relief in pain ,stiffness,twiching in the patients of gridhrasi |
At baseline day and after completion of trial |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/12/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [parulgautam50@gmail.com].
- For how long will this data be available start date provided 20-12-2022 and end date provided 20-12-2023?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Need of Study Management of sciatica in modern science involves administration of NSAIDS & Narcotics. These may help to relieve symptomatically but these may causes gastric problems. Headache dizziness live & kidney dysfunction etc. In chronic lower back pain surgical intervention is indicated but due to fear & high cost of complication patients avoids surgeries. In ayurveda various modalities of treatment are explained in Gridhrasi. Aims & Objectives of the Study : • To evaluate the efficacy of Kati basti with Kubj Prasarni taila in the management of Gridhrasi. • To evaluate the efficacy of Matra basti with Kubj prasarni taila in the management of Gridhrasi. • To study Gridhrasi w.s.r. to sciatica as per classical & modern literature. • To compare the effect of Kati basti & Matra basti with Kubj Prasarni taila in the management of Gridhrasi. Duration of the Study Group – ‘A’ Matra basti with Kubj Prasarni Taila • Total study period – Till completion of last enrolled patient. • Treatment Period - 7 days • Followup Period – 14th day, 21st day, 28th day • Dose – 30 ml Group – ‘B’ Kati basti with Kubj Prasarni Taila • Total study period – Till completion of last enrolled patient. • Treatment Period - 7 days (20 min. per sitting) • Followup Period – 14th day, 21st day, 28th day Material and Method : • No. of Groups : 2 group each having 30 patient. • Source of data : Patients attending O.P.D. & I.P.D. of Shubhdeep Ayurveda Medical College & Hospital (P.G. Institute), Indore (M.P.) • Method of data collection : Study will be carried out on the patients of O.P.D. & I.P.D. full filling the criteria of Gridhrasi. Subjective criteria: 1.Toda (Pricking Pain) 2.Stambha (Stiffness) 3.Spandan (Twiching) 4.Aruchi (Anorexia) 5.Gaurva (Heaviness) Objective Criteria: 1. SLR Test 2. Reflex 3.Bragard’s Test Investigations : For inclusion- 1.X-Ray Lumbar Spine (A.P. & Lateral View ) 2.MRI Lumbo sacral(if Needed) For Exclusion- CBC (IF Needed) REFERENCES 1. Carak samhita chikitsa sthan28/101,Dr.Brahmhanand Tripathi,Choukhamba surbharti prakashan,Varanasi. 2. Carak samhita,chikitsa sthan28/101,Vaidya Manorama hindi vyakhya Author Acharya Vidyadhar Shukla & Pro.Ravidutta Tripathi,choukhamba sanskrit Pratishthan,Delhi. 3. Charadutta chikitsa sthan22/210-214 Of Srichakrapani datta by Dr. Indradeva Tripathi,chaukhamba sanskrit bhawan,varanasi. 4. Bhaishajya Ratnavali 26/356-360 5. Sushrut sutra sthan 12/4 by Ambikadutta shastri,chaukhamba sanskrit sansthan,varanasi.
|