| CTRI Number |
CTRI/2020/02/023202 [Registered on: 10/02/2020] Trial Registered Prospectively |
| Last Modified On: |
06/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARATIVE STUDY TO KNOW THE EFFECT OF LOCAL APPLICATION OF TILA SARSAPA PASTE AND DASHANG LEPA IN REDUCING PAIN IN OSTEOARTHRITIS OF KNEE JOINT |
|
Scientific Title of Study
|
COMPARATIVE STUDY TO EVALUATE THE VEDANAHARA (ANALGESIC) EFFECT OF TILA SARSAPA PINDA AND DASHANG LEPA APPLICATION IN OF JANUSANDHIVATA (OA OF KNEE JOINT |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRO DR N R SINGH |
| Designation |
PROFESSOR (DEPARTMENT OF KAYACHIKITSA) |
| Affiliation |
CH BRAHM PRAKASH AYURVED CHARAK SANSTHAN KHERA DABAR NAJAFGARH NEW DELHI |
| Address |
ROOM NO.146 DEPARTMENT OF KAYACHIKITSA CH. BRAHM PRAKASH AYURVED CHARAK SANSTHAN, KHERA DABAR NAJAFGARH
ROOM NO.146 DEPARTMENT OF KAYACHIKITSA CH. BRAHM PRAKASH AYURVED CHARAK SANSTHAN, KHERA DABAR NAJAFGARH
South West
DELHI
110073
India |
| Phone |
9560659728 |
| Fax |
|
| Email |
naimishraj@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PRO DR N R SINGH |
| Designation |
PROFESSOR (DEPARTMENT OF KAYACHIKITSA) |
| Affiliation |
CH BRAHM PRAKASH AYURVED CHARAK SANSTHAN KHERA DABAR NAJAFGARH NEW DELHI |
| Address |
ROOM NO.146 DEPARTMENT OF KAYACHIKITSA CH. BRAHM PRAKASH AYURVED CHARAK SANSTHAN, KHERA DABAR NAJAFGARH
ROOM NO.146 DEPARTMENT OF KAYACHIKITSA CH. BRAHM PRAKASH AYURVED CHARAK SANSTHAN, KHERA DABAR NAJAFGARH
South West
DELHI
110073
India |
| Phone |
9560659728 |
| Fax |
|
| Email |
naimishraj@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
PRATEEK MADAN |
| Designation |
MD SCHOLAR (DEPARTMENT OF KAYACHIKITSA) |
| Affiliation |
CH BRAHM PRAKASH AYURVED CHARAK SANSTHAN KHERA DABAR NAJAFGARH NEW DELHI |
| Address |
ROOM NO.146 DEPARTMENT OF KAYACHIKITSA CH. BRAHM PRAKASH AYURVED CHARAK SANSTHAN, KHERA DABAR NAJAFGARH
ROOM NO.146 DEPARTMENT OF KAYACHIKITSA CH. BRAHM PRAKASH AYURVED CHARAK SANSTHAN, KHERA DABAR NAJAFGARH
South West
DELHI
110073
India |
| Phone |
7568387883 |
| Fax |
|
| Email |
madanprateek31@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kayachikitsa Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar New Delhi 11007 |
|
|
Primary Sponsor
|
| Name |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Autonomous Ayurvedic Medical college and Hospital under Govt of NCT of Delhi] |
| Type of Sponsor |
Other [ [Autonomous Ayurvedic Medical college and Hospital under Govt of NCT of Delhi] ] |
|
|
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 |
| PROF DR N R SINGH |
Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar New Delhi |
Room no 146 Deptt of Kayachikitsa New Delhi DELHI
South West
DELHI |
9560659728
naimishraj@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CBPACS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
LOCAL APPLICATION OF DASHANG LEPA |
40 patients will be randomly selected for this group and they will be treated for 15 days with 1.Local application of DASHANG LEPA as per recquirement approximately 20 gm fine powder form 2.Tab. Laksha guggulu 4 tab TDS Orally after meal with lukewarm water |
| Intervention |
LOCAL APPLICATION OF TILA SARSHAPA PINDA LEPA |
40 patients will be randomly selected for this group and they will be treated for 15 days WITH 1. Local application TILA SARSHAPA PINDA LEPA as per recquirement approximately 20 gm fine powder form 2.Tab. Laksha guggulu 4 tab TDS Orally after meal with lukewarm water |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Ambulatory as well as bed ridden patients
2. Patients with classical signs and symptoms of Sandhivata of Janu Sandhi
3. Patients having the symptoms of OA for at least 6 months
4. Patients suffering from moderate to severe knee pain with or without morning stiffness <30 minutes duration
|
|
| ExclusionCriteria |
| Details |
1. Age below 40 years and above 70 years
2. Patients with ligamental injury or in other surrounding tissues of knee joint
3. Pregnant women and complicate of OA
4. Patients with bony deformity
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Reduction in Vatapoornadrithivat-Sparsh (Feeling like putting the finger on air filled bag)
2. Reduction in Sandhishotha (Swelling in knee joint) |
DAY0DAY1DAY2TO16DAY17DAY45 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Reduction in Vedana during prasaran- Akunchana(Pain at the time of flexion and extension of joints)
2. Reduction in SandhiHanti ( Impaired joint function)
3. Reduction in Atopa (Crepitus) |
1. Vedana during prasaran- Akunchana(Pain at the time of flexion and extension of joints)
2. SandhiHanti ( Impaired joint function)
3. Atopa (Crepitus) on Day0 Day 1 Day2-16 Day17 Day45 |
|
|
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 3 |
|
Date of First Enrollment (India)
|
10/02/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
sandhivata may be correlated with degenerative joint disease or osteoarthritis in modern medical science. osteoarthritis is a chronic degenerative disorder of multi factorial etiology,characterized by loss of articular cartilage and peri-articular bone remodeling.this study is aimed to compare efficacy of tila sarshapa pinda and dashang lepa application reducing pain in case of janu sandhivata(osteoarthritis).total number of patient is 80. 40 in each group.in group a comparative group dashang lepa as per requirement. in another trial group b applied tila sarshapa as per requirement in both group will administration laksha guggulu. study design open label randomized parallel study. |