| CTRI Number |
CTRI/2024/09/073848 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
12/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
In this study 1 group will be receive nirgundi patra pinda sweda and 2nd group will be receive nirgundi taila katibasti. |
|
Scientific Title of Study
|
A comparative clinical study of nirgundi patra pinda sweda and nirgundi taila katibasti in the management of gridhrasi |
| 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 bhagyashri ashok kale |
| Designation |
md scholar panchakarma |
| Affiliation |
Sumatibhai shah ayurveda mahavidyalay |
| Address |
Sumatibhai shah ayurveda mahavidyalay malwadi hadapsar pune opd no 6 department of panchakarma sane guruji arogya kendra malwadi hadapsar pune 411028 maharashtra India
Pune
MAHARASHTRA
411028
India |
| Phone |
9169931111 |
| Fax |
|
| Email |
kalebhagya13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
dr priyanka keram |
| Designation |
assistant professor department of panchakarma |
| Affiliation |
Sumatibhai shah ayurveda mahavidyalay pune |
| Address |
Sumatibhai shah ayurveda mahavidyalay malwadi hadapsar pune opd no 6 department of panchakarma sane guruji aarogya kendra malwadi hadapsar pune 411028 maharashtra india.
Pune
MAHARASHTRA
411028
India |
| Phone |
8485022857 |
| Fax |
|
| Email |
drpriyankakeram@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
dr Bhagyashri Ashok Kale |
| Designation |
md scholar panchakarma |
| Affiliation |
Sumatibhai shah ayurveda mahavidyalay pune |
| Address |
sumatibhai shah ayurveda mahavidyalay malwadi hadapsar pune opd no 6 department of panchakarma sane guruji aarogya kendra malwadi hadapsar pune 411028 maharashtra india.
Pune
MAHARASHTRA
411028
India |
| Phone |
9169931111 |
| Fax |
|
| Email |
kalebhagya13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of panchakarma sane guruji aarogya kendra malwadi hadapsar pune 411028 |
|
|
Primary Sponsor
|
| Name |
sane guruji aarogya kendra |
| Address |
sane guruji aarogya kendra malwadi hadapsar pune 411028 maharashtra India. |
| 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 Bhagyashri Ashok Kale |
Sane guruji aarogya kendra |
Opd no 6 department of panchakarma sane guruji aarogya kendra malwadi hadapsar pune 411028 maharashtra india
Pune
MAHARASHTRA |
9169931111
kalebhagya13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| M.A.M.s SSAM and Sane Guruji Arogya Kendra Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M488||Other specified spondylopathies. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | kaTibastiH, कटिबसà¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Dr. Tripathi B, Ashtanga Hrudaya, Chaukhamba Sanskrit Pratishthana, Sutrasthana 14/18, Procedure details: Kati means lower back region. It is a procedure in which retaining
of warm medicated oil with in a specially formed frame(mould) in the lumbo
sacral region is done. It performs the combined action of snehana &
swedana.It is done for 20 minutes per day for 7 days. )
(1) Medicine Name: Nirgundi taila, Reference: Chunekar k, Bhavprakash Nighantu, Chaukhamba Sanskrit Bhavan, 114-115 Page no 344., Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | piNDasvedaH, पिणà¥à¤¡à¤¸à¥à¤µà¥‡à¤¦à¤ƒ | (Procedure Reference: Vd. Joshi Y. G, Charaksamhita, Vaidyamitra Prakashan, Sutrasthana 14/41 page no. 204., Procedure details: Application of the heat & thereby inducing
perspiration by using heated bolus of Nirgundi Patra is known as Patra Pinda
sweda. Patra Pinda Sweda is the modified form of Sankara Sweda.It is done for 20 minutes per day for 7 days. )
(1) Medicine Name: Nirgundi patra, Reference: Chunekar k, Bhavprakash Nighantu, Chaukhamba Sanskrit Bhavan, 114-115 Page no 344., Route: Topical, Dosage Form: Kalka/ Paste, Dose: 50(g), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with classical symptoms of gridhrasi
Both gender will be selected
Snehana arha
Swedana arha
Age group- 20 to 60 yrs
Patients with positive SLRT
|
|
| ExclusionCriteria |
| Details |
fracture related to LS of spine
pregnant women
spinal tuberculosis
any systemic conditions which may interfere the treatment. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of nirgundi patra pinda sweda and nirgundi taila katibasti in Gridhrasi. |
Treatment will be given for 7 days patients will be assessed on oth, 7th day and follow up on 15th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the effect of nirgundi patra pinda sweda in gridhrasi
To assess the effect of nirgundi taila katibasti in gridhrasi. |
Patients will be assessed on 0th , 7th day & follow up on 15th day. |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 1 |
|
Date of First Enrollment (India)
|
23/09/2024 |
| 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
|
This is a Comparative clinical study of two different modalities of Swedana that is Nirgundi Patra Pinda sweda and Nirgundi Taila Katibasti in Gridhrasi. The primary objective is to compare the effect of Nirgundi Patra Pinda sweda and Nirgundi Taila Katibasti in Gridhrasi. One group of Gridhrasi patients will be treated with Nirgundi patra Pinda sweda for 7 days. Second group of Gridhrasi patients will be treated with Nirgundi Taila Katibasti for 7 days. Observation will be drawn from the outcome of treatment. |