| CTRI Number |
CTRI/2023/11/060119 [Registered on: 22/11/2023] Trial Registered Prospectively |
| Last Modified On: |
18/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Agnikarma With Suvarna Shalaka Along With Oral Administration Of Dashmooladi Kwatha] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Study the efficacy of agnikarma with suvarna shalaka along with oral administration of dashmooladi kwatha in the treatment of Avabahuka (frozen shoulder) |
|
Scientific Title of Study
|
Study of efficacy of agnikarma with suvarna shalaka along with oral administration of dashmooladi kwatha in the treatment of Avabahuka with special reference to frozen shoulder- a randomised controlled clinical trial |
| 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 Khakre Lakshmikant Maheshwarappa |
| Designation |
PG Scholar |
| Affiliation |
Govt. Ayurved College Nanded |
| Address |
Dept of Shalyatantra
Govt Ayurved College Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
07588178481 |
| Fax |
|
| Email |
lakshmikant.khakre@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay P Ukhalkar |
| Designation |
Professor |
| Affiliation |
Govt. Ayurved College Nanded |
| Address |
Dept of Shalyatantra
Govt Ayurved College Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
7755921987 |
| Fax |
|
| Email |
ukhalkarvp@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay P Ukhalkar |
| Designation |
Professor |
| Affiliation |
Govt. Ayurved College Nanded |
| Address |
Dept of Shalyatantra
Govt Ayurved College Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
7755921987 |
| Fax |
|
| Email |
ukhalkarvp@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Govt Ayurved College Vazirabad Nanded |
|
|
Primary Sponsor
|
| Name |
Dr Lakshmikant Maheshwarappa Khakre |
| Address |
Dept of Shalyatantra Government Ayurved College Vazirabad Nanded |
| 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 Lakshmikant Maheshwarappa Khakre |
Government Ayurved Hospital Nanded |
Department of Shalyatantra Hospital building OPD No. 6 & 7 IPD Ward No. 51 & 63 Nanded MAHARASHTRA
Nanded
MAHARASHTRA |
7588178481
lakshmikant.khakre@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Govt. Ayurved College, Nanded |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M750||Adhesive capsulitis of shoulder. Ayurveda Condition: AVABAHUKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Su.Su.12/10 Ambika Datta Shastri ,Sushruta Samhita , Volume 1, Chaukhamba Sanskrit Sansthan; Varanasi: Reprint 2016 (Sutra 12/10 ) page no. 52. Kaviraj Atridev Gupta, Ashtang Sangraha, Volume1, Krushndas Academy; Varanasi: Reprint 1993 (Sutra 40/3 ) page no. 258 Ambika Datta Shastri ,Sushruta Samhita , Volume 1, Chaukhamba Sanskrit Sansthan; Varanasi: Reprint 2016 ( Sutra 12/7 ) page no. 51, Procedure details: Patients will be scheduled to have 4 sessions, 1 week apart, over a period of
4 weeks. In the sitting position, each marked tender point will be touched with the pin point
tip of the Panchdhatu Shalaka for approximately 0.3 to 0.5 seconds. The aim will be to
produce Samyaka Bindu Vishesh Twaka Dagdha (micro second-degree burn), with an area of
about 1-2 mm in diameter, a depth of less than 1 mm & 0.5 cm gap will be left between two
points of Dagdha.)
(1) Medicine Name: Dashmooladi kwath, Reference: Bhaishajya Ratnavali by Vd. Siddhinandan Mishra - Vatavyadhi Rogadhikar 26/28, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 50(ml), Frequency: od, Duration: 28 Days | | 2 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Su.Su.12/10 Ambika Datta Shastri ,Sushruta Samhita , Volume 1, Chaukhamba Sanskrit Sansthan; Varanasi: Reprint 2016 (Sutra 12/10 ) page no. 52. Kaviraj Atridev Gupta, Ashtang Sangraha, Volume1, Krushndas Academy; Varanasi: Reprint 1993 (Sutra 40/3 ) page no. 258 Ambika Datta Shastri ,Sushruta Samhita , Volume 1, Chaukhamba Sanskrit Sansthan; Varanasi: Reprint 2016 ( Sutra 12/7 ) page no. 51, Procedure details: Patients will be scheduled to have 4 sessions, 1 week apart, over a period of
4 weeks. In the sitting position, each marked tender point will be touched with the pin point
tip of the suvarna Shalaka for approximately 0.3 to 0.5 seconds. The aim will be to
produce Samyaka Bindu Vishesh Twaka Dagdha (micro second-degree burn), with an area of
about 1-2 mm in diameter, a depth of less than 1 mm & 0.5 cm gap will be left between two
points of Dagdha. Suvarna Shalaka will be placed over marked p)
(1) Medicine Name: Dashmooladi kwath, Reference: Bhaishajya Ratnavali by Vd. Siddhinandan Mishra - Vatavyadhi Rogadhikar 26/28, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 50(ml), Frequency: od, Duration: 28 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Selection of patient will be done irrespective of sex, religion, occupation, socio-economic status.
2. Patient with classical signs & symptoms of Frozen shoulder with duration up to 2 years.
3. Patient between age Group of 40 and 70 years.
4. Patients with controlled diabetes mellitus(FBS: <140mg/dl, PPBS:<180mg/dl) with or without medication.
5. Patients fit for Agnikarma. |
|
| ExclusionCriteria |
| Details |
1. Patient with Acute Traumatic Disorders of Shoulder Joints.
2. Subluxations or recurrent dislocations of the shoulder joints.
3. Patient suffering from arthritis like Osteoarthritis, Gouty arthritis, etc.
4. Immunocompromised patients such as HIV, HbsAg & RTPCR positive patients.
5. Patients suffering from rotator cuff injuries, other diseases like paralysis, parkinson’s disease, cardiac diseases, renal diseases, endocrine diseases, severe anaemia, malignancy, pregnant & lactating female.
6. Patients with uncontrolled diabetes mellitus.(fasting blood sugar (FBS):>140mg/dl, postprandial blood sugar (PPBS):>180mg/dl) |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
improvement in predefined parameters i.e,
Sandhi shoola (pain), Sandhi graha (stiffness), Bahupraspanda Haratvam (Range of Movements) using
goniometer. |
28days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.To achieve relief of pain in Frozen shoulder 2.To evaluate the improvement in the movements of shoulder joint. |
28days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/12/2023 |
| 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="3"
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 study is a prospective, randomized, open labelled, controlled clinical study of efficacy of agnikarma with suvarna shalaka along with dashmooladi kwath 50ml once a day in evening for one month with follow up and assessment on 1st , 8th, 15th,22nd and 29th day in the treatment of avabahuka with special reference to frozen shoulder. The primary objective is to study the efficacy of suvarna shalaka along with dashmooladi kwath in the treatment of avabahuka with special reference to frozen shoulder.This study is conucted as PG course at a single centre. |