| CTRI Number |
CTRI/2021/03/031635 [Registered on: 01/03/2021] Trial Registered Prospectively |
| Last Modified On: |
26/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to see the effect of punarnavadi pinda sweda in patients suffering with low back ache |
|
Scientific Title of Study
|
A randomized controlled clinical trial to evaluate the efficacy of punarnavadi pinda sveda in katigraha |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rashmi Nanda |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College |
| Address |
Dr Rashmi Nanda
PG Scholar
Department of Panchakarma
Alvas Ayurveda Medical College
Moodbidri
Dakshina kannada district
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
7795639485 |
| Fax |
|
| Email |
rashminanda95@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikram kumar |
| Designation |
Associate Professor |
| Affiliation |
Alvas Ayurveda Medical college |
| Address |
Dr Vikram Kumar
Associate Professor
Department of Panchakarma
Alvas Ayurveda Medical College
Moodbidri
Dakshina kannada district
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9483141326 |
| Fax |
|
| Email |
vikramkumar83@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Nanda |
| Designation |
PG Scholar |
| Affiliation |
Alvas Ayurveda Medical College |
| Address |
Dr Rashmi Nanda
PG Scholar
Department of Panchakarma
Alvas Ayurveda Medical College
Moodbidri
Dakshina kannada district
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
7795639485 |
| Fax |
|
| Email |
rashminanda95@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma
Alvas Ayurveda Medical college moodbidri
dakshina kannada
karnataka |
|
|
Primary Sponsor
|
| Name |
Dr Rashmi Nanda |
| Address |
#001 sriya paradise ananthapura village yelahanka hobli bengaluru karnataka 560064 |
| Type of Sponsor |
Other [self] |
|
|
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 Rashmi Nanda |
Alvas Ayurveda Medical College |
panchakarma theatre department of panchakarma room number 201 2nd floor
Alvas Ayurveda Medical College
Vidyagiri Moodbidri
Dakshina Kannada
KARNATAKA |
7795639485
rashminanda95@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Clinical Ethics Committee Alvas Ayurveda Medical College |
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: KATIGRAHA, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Kolakulathadi pinda sveda |
Poorva karma
Kola,Kulatha,suradaru,rasna,masha,atasi,tila,kusta,vacha,shatahwa,yava are taken in equal quantity and pound.
The powdered drugs are mixed with kanji and made into 2 pottali of 250 g each.
Sthanika abhyanga is done with moorchitha tila taila.
Pradhana karma-
Pottalis are steamed by placing it over vessel containing kanji.
The temperature of the potTali is tested by placing it over the dorsum of the hand.
Sukoshna pottali is placed over the lumbar region.
Paschath karma-
Patient is asked to lied down for 15mins following which Sukoshna jala snana is adviced.
|
| Intervention |
Punarnavadi Pinda Sveda |
Poorva Karma-punarnava,eranda,yava,atasi,masha,karpasa asti are taken in equal quantity and made into powder.
2 pottalis of 250 gram each are prepared by mixing the powdered drugs in kanji.
Stanika abhyanga is done on kati pradesha with moorchitha tila taila.
Pradhana Karma-
pottalis are steamed by placing it over vessel containing kanji.
temperature is tested by placing over dorsum of hand.
Sukoshna pottali is applied over lumbar region.
Treatment is carried for 30mins.
Paschath karma-
Lie down and rest for 10-15 mins followed by hot water bath. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients presenting symptoms of katigraha.
low back ache of mechanical origin and IVDP without radiating.
Patients who are fit for swedana karma |
|
| ExclusionCriteria |
| Details |
Patinets with low back ache of non mechanical origin.
patients with history of trauma
post surgical back ache.
sciatica |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain in the region of Kati
Stiffness in the region of Kati
tenderness
range of motion
walking time |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/03/2021 |
| 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 - NO
|
|
Brief Summary
|
It is a randomized controlled clinical trial to evaluate the efficacy of Punarnavadi Pinda sveda in katigraha.The study consists of two groups a trial group (Punarnavadi Pinda Sveda) and a control group (Kolakulathadi Pinda Sveda).40 patients of katigraha (20 in each group) are selected by randomization technique from Alvas Ayurveda Medical College.The patients of respective group are administered with respective pinda sveda for a period of 7 days.The pre and post treatment assessments are made and the follow up is done on the 14th day. |