CTRI Number |
CTRI/2023/01/048704 [Registered on: 03/01/2023] Trial Registered Prospectively |
Last Modified On: |
02/01/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Ayurveda Other (Specify) [Curative] |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
A clinical study to compare the combined effect of viddha plus agnikarma with only viddha karma in avabahuka special reference to frozen shoulder |
Scientific Title of Study
|
A randomized comparative clinical trial to evaluate combined efficacy of viddha karma plus
agnikarma with only viddha karma in avbahuka. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Sneha Jadhav |
Designation |
PG Scholar |
Affiliation |
PDEAS College of Ayurved and Research Centre, Nigdi, Pune |
Address |
PDEAS College of Ayurved and Research Centre, Third Floor, Shalyatantra department Sector no. 25, Nigdi, Pradhikaran, Pune - 411044
Pune MAHARASHTRA 411044 India |
Phone |
08390616669 |
Fax |
|
Email |
jsneha58@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Madhavi S Banarase |
Designation |
HOD Shalyatantra Department |
Affiliation |
PDEAS College of Ayurved and Research Centre, Nigdi, Pune |
Address |
PDEAS College of Ayurved and Research Centre, Third Floor, Shalyatantra department Sector no. 25, Nigdi, Pradhikaran, Pune - 411044
Pune MAHARASHTRA 411044 India |
Phone |
9423207569 |
Fax |
|
Email |
dr.madhavibanarase209@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Sneha Jadhav |
Designation |
PG Scholar |
Affiliation |
PDEAS College of Ayurved and Research Centre, Nigdi, Pune |
Address |
PDEAS College of Ayurved and Research Centre, Third Floor, Shalyatantra department Sector no. 25, Nigdi, Pradhikaran, Pune - 411044
Pune MAHARASHTRA 411044 India |
Phone |
08390616669 |
Fax |
|
Email |
jsneha58@gmail.com |
|
Source of Monetary or Material Support
|
PDEAS College of Ayurved and Research Centre, sector no. 25, Pradhikaran, Nigdi, Pune 411044 |
|
Primary Sponsor
|
Name |
PDEAS College of Ayurved and Research Centre, Nigdi Pune |
Address |
PDEAS College of Ayurved and Research Centre, Sec.no.25 Pradhikaran, Nigdi, Pune 411044 |
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 |
Dr Sneha Jadhav |
Ayurved Rugnalay and Sterling Multispeciality Hospital |
Shalyatantra OPD, OPD no. 123, ground floor, Sector.27, bhel chowk, pradhikaran, nigdi, pune 411044 Pune MAHARASHTRA |
08390616669
jsneha58@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Commitee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:M256||Stiffness of joint, not elsewhereclassified. Ayurveda Condition: AVABAHUKAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•रà¥à¤® plus vedhan karma | (Procedure Reference: SUSHRUT SAMHITA, Procedure details: Most tender point will be marked then cleaned with spirit swab and disposable needle will be pierced at 45 degrees of angle upto 3 to 4 mm depth and then later Agnikarma will be done with panchdhatu shalaka in once a week for 21 days.)
| 2 | Comparator Arm | Procedure | - | vedhana-karma, वेधन-करà¥à¤® | (Procedure Reference: SUSHRUT SAMHITA, Procedure details: Most tender point will be marked then cleaned with spirit swab and disposable needle will be pierced at 45 degrees of angle upto 3 to 4 mm depth in once a week for 21 days.)
|
|
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patients diagnosed as frozen shoulder.(adhesive capsulitis)
Patients of age group 20-60 years.
Patients irrespective of gender, caste, religion, economical status.
All patients having pain and restricted movements at shoulder joint in presence of
normal plane. |
|
ExclusionCriteria |
Details |
Pregnancy
Patient suffering from major trauma having dislocation, Rotator cuff injury or fracture.
Patient suffering from any major systemic disorders like, Hypertension, Ischemic Heart
disease, Gout and rheumatoid arthritis.
Those patients who need other emergency interventions like surgery and other means
are excluded.
K/C/O HIV, HBsAg.
Patient with Malignancy and Immuno-compromised disorders.
Patients with uncontrolled Diabetes mellitus |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Alternation |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
In once a week for 21 days the effect of Viddha karma plus Agnikarma on the Avabahuka pain relief will be accessed with the effect of only viddha karma. |
Total 21 days treatment
Difference in pain and stiffness will be observed on 0, 7th, 14th, and 21st day. |
|
Secondary Outcome
|
Outcome |
TimePoints |
To study adverse effects, if any |
Total 21 days treatment
Difference in pain and stiffness will be observed on 0, 7th, 14th, and 21st day. |
|
Target Sample Size
|
Total Sample Size="62" Sample Size from India="62"
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
|
N/A |
Date of First Enrollment (India)
|
05/01/2023 |
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
|
None yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
In textual refrences of Ayurveda, Avabahuka is described as vata vadhi in which vata dosha is localized in the shoulder region, when Vata gets vitiated, it dries up the ligaments of the shoulders and constricts the Siras present there and causes Avabahuka. In modern, Frozen shoulder is a condition characterized by stiffness and pain in the shoulder joint. Frozen shoulder is also called adhesive capsulitis as the shoulder capsule thickens and becomes stiff and tight. Thick bands of tissue called adhesions develop. This typically occurs in cycle of 3 stages as painful phase, stiff phass and thawing phase which can be correlated to avabahuka in ayurveda. In Ayurveda literature, Acharya Sushruta has given the description of Viddha karma and Agnikarma as a parasurgical procedures are unique therapeutic procedures because of its primitive, preventive and prophylactic properties. •Viddha Karma - viddha karma is a miniature of bloodletting procedure. A very small puncture or piercing certain points that helps in reducing pain. It acts as pain reliever by releasing Endorphin that helps to reduce pain in body. • Viddha karma plus Agnikarma- With Viddha karma Agnikarma can be done in circular manner, or Appling dot at most tender point or parallel linings at the tender point. So viddha karma and agnikarma to the maximum tenderness points of shoulder may release the Vataavrodha and ultimately pain will be decreased. When pain is relieved, the patient will definitely try to make the active movements of his arm. |