| CTRI Number |
CTRI/2024/05/067830 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Single arm clinical study ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study to evaluate efficacy of Shunti Ghruta matra basti Basti in management of katisandhigata vata (lower back pain) |
|
Scientific Title of Study
|
Clinical study to evaluate efficacy of shunthi ghruta matra basti in management of katisandhigata vata |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Priyanka Datta Kshirsagar |
| Designation |
MD scholar panchakarma |
| Affiliation |
Tilak Ayurvedic Mahavidyalaya,Pune Department of Panchakarma |
| Address |
Tilak Ayurved Mahavidyalaya rasta peth Pune
Maharashtra
India
Tilak Ayurved Mahavidyalaya rasta peth Pune
Department of panchkarma
Maharashtra
Pune
MAHARASHTRA
411011
India |
| Phone |
9657294736 |
| Fax |
|
| Email |
priyanka19nsdk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajendra S Huparikar |
| Designation |
HOD Panchakarma department |
| Affiliation |
Tilak Ayurvedic Mahavidyalaya,Pune |
| Address |
Tilak Ayurved Mahavidyalaya rasta peth Pune
Maharshtra
India
Tilak Ayurved Mahavidyalaya rasta peth Pune
Department of panchkarma
Maharashtra
India
Pune
MAHARASHTRA
411011
India |
| Phone |
9823050402 |
| Fax |
|
| Email |
ayurvedapune@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Rajendra S Huparikar |
| Designation |
HOD Panchakarma |
| Affiliation |
Tilak Ayurvedic Mahavidyalaya,Pune |
| Address |
Tilak Ayurved Mahavidyalaya rasta peth Pune
department of Panchakarma
Tilak Ayurved Mahavidyalaya rasta peth Pune
Department of panchkarma
Maharashtra
Pune
MAHARASHTRA
411011
India |
| Phone |
9823050402 |
| Fax |
|
| Email |
ayurvedapune@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tilak Ayurveda Mahavidhyalaya and Seth Tarachand ramnath charitable ayurved hospital , rasta peth pune,411011 Maharashtra |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalayapune |
| Address |
rasta peth Pune 411011
Maharashtra
|
| 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 Priyanka Datta Kshirsagar |
Tilak Ayurveda Mahavidhyalaya and Seth Tarachand ramnath dharmartha hospital |
OPD No 12 first floor Rasta peth Pune
Pune
MAHARASHTRA |
9657294736
priyanka19nsdk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| tilak ayurveda mahavidyalaya institutional committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M169||Osteoarthritis of hip, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: charak sidhhisthan adhyay 4 shloks no. 52, Procedure details: lukewarm 60 ml shunthi ghruta loaded in 100 cc glycerine syringe will be delivered into pakwashaya with the help of rubber catheter which will be introduced per rectum.)
(1) Medicine Name: shunthi ghruta, Reference: bhaishajya ratnavali aamvata vyadhi shlok no. 14, Route: Rectal, Dosage Form: Ghrita, Dose: 60(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either gender between 30 years to 70 years with presenting following symptoms and ready to give writen consent and voluntary participation
Symptoms are prasaran aakunchana vedana, katishool,katigraha,sparshaasahtva. |
|
| ExclusionCriteria |
| Details |
Fracture of spinal cord, patients who are contraindicated for basti as per bhrihtayi, spinal stress, spine curvature (scoliosis or kyhphosis), acute lower back pain, cancer involving spine, compression fractures to the spine, infection of spine(osteomyelitis,abscess), kidney stone,kidney infection, Psoriatic arthritis, problems related to pregnancy, conditions like ankyloses spondylosis, known case of cardiac disease, pulmonary TB, pregnancy,HIV, medical conditions including female reproductive organs like endometriosis, ovarian cyst, ovarian cancer , uterine fibroids. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate efficacy of Shunthi Ghruta Matra basti in the management of Katisandhigata vaata |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| decrease in symptoms like katishool, akunchan prasaran vedana and katigraha. |
30 days |
|
|
Target Sample Size
|
Total Sample Size="27"
Sample Size from India="27"
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)
|
15/06/2024 |
| 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 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
|
Number of patients suffering from sandhigata vata katisandhigata ata is particularly high and thus it is important to work on it. Panchakarma is very unique therapeutic procedure because of its preventive promtive prophylactic and rejuvinative properties as well as providing radical cute. In charak samhita for asthi pradoshaj vikar panchakarma treatment is described. Among these panchakarma basti karma is prime treatment it is considered best treatment for vata dosha and it’s stated to be ardhachikitsa for the same Shunthi ghruta comprises drugs like shunthi and ghruta it is considered as shulaghna , vataghna, and ghruta is vatapittashamk, balya so I have decided to work on shunthi ghruta matra basti and establish its effect on katisandhigata vata . |