| CTRI Number |
CTRI/2020/08/027159 [Registered on: 14/08/2020] Trial Registered Prospectively |
| Last Modified On: |
27/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study for relieving pain and restoring mobility of joints in the patients of Frozen shoulder, calcaneal spur, knee osteoarthritis, tennis elbow with the help of electrocautery to radiate heat around painful site and achieve results. |
|
Scientific Title of Study
|
Study the effectiveness of ‘cauterization with electro cautery’ as Agnikarma in the management of specific Agnikarma Sadhya Vyadhies: Randomized Controlled Clinical Trial |
| Trial Acronym |
Dahan |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suresh Shivajirao Podhade |
| Designation |
Associate Professor |
| Affiliation |
Shri Gurudeo Ayurveda College |
| Address |
Department of Shalyatantra, Room no. 16, Shri Gurudeo Ayurveda College, Gurukunj Ashram, Tq. Tiosa Dist. Amravati
Department of Shalyatantra, Room no. 16, Shri Gurudeo Ayurveda College, Gurukunj Ashram, Tq. Tiosa Dist. Amravati
Amravati
MAHARASHTRA
444902
India |
| Phone |
9850036968 |
| Fax |
07225224229 |
| Email |
sspodhade18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Rajendra Badwe |
| Designation |
Professor Guide |
| Affiliation |
Shri Ayurveda Mahavidyalaya, Nagpur |
| Address |
Department of Shalyatantra, Shri Ayurveda Mahavidyalaya, Dhanvantari Marg, Hanuman Nagar, Nagpur
Department of Shalyatantra, Shri Ayurveda Mahavidyalaya, Dhanvantari Marg, Hanuman Nagar,
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9011060498 |
| Fax |
07122742592 |
| Email |
dryogesh.badwe@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suresh Shivajirao Podhade |
| Designation |
Associate Professor |
| Affiliation |
Shri Gurudeo Ayurvdea College, Gurukunj Ashram |
| Address |
Department of Shalyatantra, Room no. 16, Shri Gurudeo Ayurveda College, Gurukunj Ashram, Tq. Tiosa, Dist. Amravati
Department of Shalyatantra, Room no. 16, Shri Gurudeo Ayurveda College, Gurukunj Ashram, Tq. Tiosa, Dist. Amravati
Amravati
MAHARASHTRA
444902
India |
| Phone |
9850036968 |
| Fax |
07225224229 |
| Email |
sspodhade18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Ayurved College, Dhanvantari Marg, Hanuman Nagar, Nagpur 440024 |
|
|
Primary Sponsor
|
| Name |
Shri Ayurved College |
| Address |
Dhanvantari Marg, Hanuman Nagar, Nagpur |
| Type of Sponsor |
Other [Grant-in-aid ayurveda 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 Suresh Shivajirao Podhade |
Shri Gurudeo Ayurved Rugnalaya, |
Department of Shalyatantra,Room no. 16 Shri Gurudeo Ayurveda Rugnalaya,A/p. Gurukunj Ashram, Tq. Tiosa, Dist. Amaravtai
Amravati
MAHARASHTRA |
9850036968
07225224229
sspodhade18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Istitutional Ethics Committee Shri Ayurved Mahavidyalaya Nagpur |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Agnikarma with Traditional Method described by Sushrut Samhita |
Pancha Dhatu Shalaka with 0.5 cm diameter tip Heated on flame until it becomes hot red. Agnikarma in the form of samyak twak dagdha (therapeutic superficial skin burn) as done by making a Binduvat dahana vishesa (single dot at maximum tender site) with dahanopakarana Appropriate precaution will be taken not to produce asamyak dagdha vrana |
| Intervention |
i)Cauterization with Electrocautery |
i) To achieve lakshana of samyakdagdha by Cauterization with Electrocautery of 300 mAmp with intensity at 1 to relieve pain and improve mobility of affected part in Avabahukaa, Vatakantakaa, Janu Sandhigat Vata and Snayugat Vata
ii) To establish convenient method to perform Agnikarma using single
instrument i.e. Electrocautery.
Three sittings of Cauterization at an interval of three weeks will be done to assess the symptmps of these diseases and observations will be tabulized and conclusion will be drawn accordingly. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Adult patients with age group from 21 to 65 years.
2) OPD and IPD patients complaining or presenting clinical signs and symptoms of Agnikarma sadhya vadhys such as Vatkantak, Janu sandhigat vat, Avabahukaa, Snayugat Vata will be examined, diagnosed and included in respective group for further study.
|
|
| ExclusionCriteria |
| Details |
1) Pregnant woman will not include in this study.
2) Patients taking other treatment from any pathy for the same problem during clinical trial.
3) Patients who are suspected of serious systemic disease i.e. DM, TB, Hypertension, malignancy, or having any other complicated systemic diseases
4) Other diseases such as paralysis, Parkinson’s disease, severe anaemia, and patients
5) Patients having diseases included in study as secondary to other disease will be excluded.
6) patients having associated symptoms which are contraindicated for Agnikarma will be excluded from study.
7) Durbala, balaka, vruddha, bhiroo, anekavranapidita, Aswedya patients will not be included in this study.
8) Patients with Pittaprakriti, Raktapitta, Bhinnakoshtha (Atisara), Anudhrutashalya, will not be included in this study.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| i) To achieve lakshana of samyakdagdha by Cauterization with Electrocautery of 300 mAmp with intensity at 1 to relieve pain and improve mobility of affected part in Avabahukaa, Vatakantakaa, Janu Sandhigat Vata and Snayugat Vata |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ii) To establish convenient method to perform Agnikarma using single instrument i.e. Electrocautery. |
3 weeks |
|
|
Target Sample Size
|
Total Sample Size="284"
Sample Size from India="284"
Final Enrollment numbers achieved (Total)= "284"
Final Enrollment numbers achieved (India)="284" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
17/08/2020 |
| Date of Study Completion (India) |
09/11/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Agnikarma is one of the important Anushalyakarma (Para surgical process). Agnikarmais the best treatment for many disorders amongst all Para surgical procedures because the diseases cured by Agnikarma will never reoccur Though Agnikarma is best modality but its traditional procedure has its own limitations due to its complex structure and various procedural differences in different conditions. It is need of time to develop and use sophisticated instrument with measurable parameters so that procedure is universally acceptable and reproducible. Electrocautery, also known as thermal cautery, refers to a process in which a direct or alternating current is passed through a resistant metal wire electrode, generating heat. The heated electrode is then applied to living tissue to achieve hemostasis or varying degrees of tissue destruction3. Each electrocautery device can deliver heat at a single temperature or range of temperatures, between 100oC and 1200oC. Most devices also include interchangeable tips such as loops, fine tips, and needle tips4. Thus electrocautery which is sophisticated instrument having varying standardized intensities can be used as Agnikarma instrument to simplify all the problems. Agnikarma using these instruments will be more easy as well as standardized after which the use of Agnikarma Chikitsa will be increased and also the analysis of the textual facts can be verified on different scales so that the perfect interpretation of this procedure and its remarkability will be proved. Certain Agnikarma sadhya vyadhi are selected for assessment of this study after detailed review of previous work and depending on availability of patients in our OPD. Those are Avabahukaa (Frozen Shoulder), Vatakantakaa (Calcaneal Spur), Janu sandhigat vat (Osteo Arthritis), Snayugat Vata (tenis elbow). Pain is important symptom in these diseases. In previous study it was observed that all these diseases were treated satisfactorily by Agnikarma. In all studies Agnikarma was carried out with different instruments. Hence to evaluate same efficacy with a single instrument i.e. electrocautery current study is selected. Current Study is having novelty in selection of operating procedure for Agnikarma. It is Open Labeled, Randomized Controlled Clinical Study. Electrocautery as Agnikarma device will be selected and tested for its effectiveness with traditional Agnikarma procedure in Twakdagdha sadhya vyadhi. Clinical study will be carried out in two groups. Observation from both groups will be noted. Analyzed statistically and Discussed with conclusion after study. |