| CTRI Number |
CTRI/2023/02/050021 [Registered on: 23/02/2023] Trial Registered Prospectively |
| Last Modified On: |
22/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Randomized Controlled Clinical study to compare the efficacy of Dashmool Choorna Pottali Hot Fomentation with Dashmool Kwatha Nadi Hot Fomentation in the management of Neck stiffness/Pain |
|
Scientific Title of Study
|
A Randomized Controlled Clinical study to compare the efficacy of Dashmool Choorna Pottali Sweda with Dashmool Kwatha Nadi Sweda in the management of Manyastambha |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Prabhakarrao Mahajan |
| Designation |
MD Scholar Panchakarma |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Seth Tarachand Ramnath Ayurved Hospital
Rasta Peth
Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
8888748821 |
| Fax |
|
| Email |
poojapmahajan373@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Anjali Vinayak Damle |
| Designation |
Assisstant Professor |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Seth Tarachand Ramnath Ayurved Hospital
Rasta Peth
Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9764136366 |
| Fax |
|
| Email |
anjali.damle@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Vd Anjali Vinayak Damle |
| Designation |
Assisstant Professor |
| Affiliation |
Tilak Ayurved Mahavidyalaya |
| Address |
Seth Tarachand Ramnath Ayurved Hospital
Rasta Peth
Pune
Pune
MAHARASHTRA
411011
India |
| Phone |
9764136366 |
| Fax |
|
| Email |
anjali.damle@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma
Tarachand Hospital Pune |
|
|
Primary Sponsor
|
| Name |
Tilak Ayurved Mahavidyalaya |
| Address |
Tarachand Hospital
Rasta Peth
Pune -411011 |
| 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 Pooja Prabhakarrao Mahajan |
Tilak Ayurved Mahavidyalaya |
OPD No. 12
Panchakarma Department Tarachand Hospital
Rasta Peth
Pune-411011
l
Pune
MAHARASHTRA |
8888748821
poojapmahajan373@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tilak Ayurved Mahavidyalaya and Tarachand Ramnath Charitable Hospital Instiitutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M489||Spondylopathy, unspecified. Ayurveda Condition: MANYASTAMBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | tApasvedaH ताप>ेदः | (Procedure Reference: Chakaradatta, Procedure details: The Choorna is heated in the pan and then taken on the cloth and tied in the form of pottali. Then according to anatomical structure of joint the pottali is moved either circular or clockwise manner. This is done till the desired area is adequately fomented. This procedure is done once in a day for 7 days.)
(1) Medicine Name: Dashamoola, Reference: Chakaradatta, Route: Topical, Dosage Form: Churna/ Powder, Dose: 100(g), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | nADIsvedaH नाडीeेदः | (Procedure Reference: Charak, Procedure details: Apply the steam from the cooker with the help of rubber pipe from a proper distance once a day for 7 days)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients of Manyastamba complaining of Ruk, stambh,pidanasahatva
2 Gender - Male and Female
3 Age Group - 20-70 years
4 Swedana arha |
|
| ExclusionCriteria |
| Details |
1 Swedana Anarha
2 Cervical Radiculopathy
3 Ankylosis
4 Cervical Myelopathy
5 Any other systemic conditions which may
interfere the treatment - K/C/O TB, CA
6 Rheumatoid Arthritis
7 Cervical vertebral fracture |
|
|
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 |
| Dashmool Choorna Pottali Sweda Is More Benificial Than Dashmool Kwatha Nadi Sweda |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/03/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/03/2023 |
| 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
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomized controlled clinical study to compare the efficacy of Dashmool choorna pottali sweda with Dashmool kwath nadi sweda in the management of Manyastambha . Its primary objective is to study that dashmool choorna pottali sweda is more effective than dashmool kwath nadi sweda . Observation will be drawn from the outcome of patients. |