| CTRI Number |
CTRI/2023/10/059214 [Registered on: 27/10/2023] Trial Registered Prospectively |
| Last Modified On: |
18/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Grudhraseehar tail and Vajigandhadi tail Matra basti in management of Grudhrasee(Sciatica) |
|
Scientific Title of Study
|
A Randomised controlled clinical trial to evaluate efficacy of Grudhraseehar tail Matra basti and Vajigandhadi tail Matra basti in the management of Grudhrasee |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VdManasi Mahadeo Sanap |
| Designation |
PG scholar |
| Affiliation |
PDEAS COLLEGE OF AYURVED AND REASEARCH CENTRE SECTOR NO 25 NIGADI PUNE 411044 |
| Address |
PDEA COLLEGE OF AYURVED AND REASEARCH CENTRE THIRD FLOOR PANCHKARMA DEPARTMENT SECTOR NO 25 NIGADI PUNE MAHARASHTRA
PUNE 411044
MAHARASHTRA
411044
INDIA
Pune
MAHARASHTRA
411044
India |
| Phone |
9356362004 |
| Fax |
|
| Email |
manasisanap2312@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVarsha Sane |
| Designation |
Professor |
| Affiliation |
PDEAS COLLEGE OF AYURVED AND REASEARCH CENTRE SECTOR NO 25 NIGADI PUNE |
| Address |
PDEAS COLLEGE OF AYURVED AND REASEARCH CENTRE THIRD FLOOR PANCHKARMA DEPARTMENT SECTOR NO 25 NIGADI PUNE MAHARASHTRA
PUNE
MAHARASHTRA
411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9923800634 |
| Fax |
|
| Email |
varsha.kale80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VdManasi Mahadeo Sanap |
| Designation |
PG Scholar |
| Affiliation |
PDEAS COLLEGE OF AYURVED AND REASEARCH CENTRE SECTOR NO 25 NIGADI PUNE |
| Address |
PDEAS COLLEGE OF AYURVED AND REASEARCH CENTRE THIRD FLOOR PANCHKARMA DEPARTMENT SECTOR NO 25 NIGADI PUNE MAHARASHTRA
PUNE
MAHARASHTRA
411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9356362004 |
| Fax |
|
| Email |
manasisanap2312@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAS COLLEGE OF AYURVED AND
REASEARCH CENTRE SECTOR NO 25 NIGADI PUNE 411044. |
|
|
Primary Sponsor
|
| Name |
PDEAS COLLEGE OF AYURVED AND REASEARCH CENTRE NIGADI PUNE 411044. |
| Address |
PDEAS COLLEGE OF AYURVED AND REASEARCH CENTRE SECTOR NO 25 NIGADI PUNE 411044 |
| 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 |
| Vd Manasi Sanap |
Ayurved Rugnalaya And Sterling Multispeciality Hospital nigadi pradhikaran pune |
Ayurved Rugnalaya And Sterling Multispeciality Hospital Panchkarma department OPD no.216 nigadi pradhikaran Pune Maharashtra 411044
Pune
MAHARASHTRA |
9356362004
manasisanap2312@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PDEA COLLEGE lnstitutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. 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 siddhisthan , Procedure details: 60 ml/day )
(1) Medicine Name: Vajigandhadi tail, Reference: Yogratnakar sanhita , Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 8 Days | | 2 | Intervention Arm | Procedure | - | Matra basti | (Procedure Reference: Charak siddhisthan, Procedure details: 60ml/day)
(1) Medicine Name: Grudhraseehar tail, Reference: Bharatbhaishajya Ratnakar , Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 8 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient irrespective with caste , religion, economic status.having signs and symptoms Grudhrasee ruja,stambha,suptata,tandra, gaurav and arochak |
|
| ExclusionCriteria |
| Details |
Contraindicates for bastichikitsa
Known cases of ulcerative colitis,GIT problems, Irritable bowel syndrome
Pregnancy and lactating mother
Pitta prakritij persons,pittaj vyadhi,Ushna kali |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine efficacy of Grudhraseehar tail Matra basti and Vajigandhadi tail Matra basti in management of Grudhrasee in 8 days |
To determine efficacy of Grudhraseehar tail Matra basti and Vajigandhadi tail Matra basti in management of Grudhrasee in 8 days |
|
|
Secondary Outcome
|
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2023 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Grudhrasee is a disease which hampers individuals day to day activities.It is considered as shoolpradhan vyadhi.The cardinal signs and symptoms are Ruka, Toda, Stambha, Muhuspandan kati, uru, janu, jangha and pada in order and Sakthikshepnigraha. Grudhrasee is disease came under vatvyadhi and Basti is main treatment for vatvyadhi.Hence Basti is best mode of administration of drug.Basti has been told as ardhachikitsa by all acharyas.Matra Basti is type of Sneha Basti which can be given in all seasons without any strict regimen of Ahara Vihara. This present study designed to evaluate efficacy of Matra Basti using two different medicated oil preparations that Basti of Grudhraseehar tail and Vajigandhadi tail |