| CTRI Number |
CTRI/2024/12/078686 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
11/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Pain Management In Manyasambha By Agnikarma Yantra Using Suvarna And Rajat Metal Tips. |
|
Scientific Title of Study
|
A Comparative Randomized Clinical Study Of Pain Management In Manyastambha (Cervical Spondylitis) In Age Group Of 18 To 60 Years By Agnikarma Yantra (Thermal Cautery) Using Suvarna And Rajat Metal Tips. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amol Prabhakarrao Shrirao |
| Designation |
PG Scholar (Shalyatantra) |
| Affiliation |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya and L.K.Ayurved Rugnalaya,Yavatmal |
| Address |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with
L.K.Ayurved Rugnalaya,Department of Shalyatntra,Ground floor
OPD No.05, Yavatmal
Yavatmal
MAHARASHTRA
445001
India
Yavatmal MAHARASHTRA 445001 India |
| Phone |
7709712703 |
| Fax |
|
| Email |
amolshrirao786@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Vihar R Bidwai |
| Designation |
Associate Professor, M.S.(Shalya), MBA, PhD(Sch.), FARCS & PG Guide |
| Affiliation |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya and L.K.Ayurved Rugnalaya,Yavatmal |
| Address |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with
L.K.Ayurved Rugnalaya,Department of Shalyatntra,Ground floor
OPD No.05, Yavatmal
Yavatmal
MAHARASHTRA
445001
India
Yavatmal MAHARASHTRA 445001 India |
| Phone |
9822299174 |
| Fax |
|
| Email |
drviharbidwai@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Amol Prabhakarrao Shrirao |
| Designation |
PG Scholar (Shalyatantra) |
| Affiliation |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya and L.K.Ayurved Rugnalaya,Yavatmal |
| Address |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with
L.K.Ayurved Rugnalaya,Department of Shalyatntra,Ground floor
OPD No.05, Yavatmal
Yavatmal
MAHARASHTRA
445001
India
Yavatmal MAHARASHTRA 445001 India |
| Phone |
7709712703 |
| Fax |
|
| Email |
amolshrirao786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with L.K.Ayurved Rugnalaya, Shivaji
nagar, Aarni road, Yavatmal 445001 |
|
|
Primary Sponsor
|
| Name |
DMM Ayurved Mahavidyalaya,Yavatmal |
| Address |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya affiliated with
L.K.Ayurved Rugnalaya, Department of Shalyatantra, Ground floor
OPD No.05, Shivaji Nagar,Yavatmal, Aarni road Dist.Yavatmal
445001 |
| Type of Sponsor |
Other [Other [(Research institution and hospital)]] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Amol Prabhakarrao Shrirao |
Dayabhai Maoji Majithiya Ayurved Mahavidyalaya and L.K.Ayurved Rugnalaya,Yavatmal |
OPD NO.05
Department of
Shalyatantra, Shivaji
nagar, Aarni road,
Yavatmal 445001
Yavatmal
MAHARASHTRA Yavatmal MAHARASHTRA |
7709712703
amolshrirao786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee, D.M.M. Ayurved Mahavidyalaya, Yavatmal |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: MANYASTAMBAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•रà¥à¤® | (Procedure Reference: Sushrut samhita, Kaviraj Vd. Ambikadattashastri, Sutrasthan adhyay 12/4. Chaukhambha publication, Reprint 2018. page no.51, Procedure details: (Procedure details: Follow-up will be taken on Days 0, 7, 14, 21 & after 45 days if there is a recurrence. Agnikarma using Rajat shalaka tip, vidhi 1. Purva Karma Proper Informed consent of the patient will be taken. Part preperation. Instrument preparation. Position of the patient will be given. 2. Pradhan karma Agnikarma will be done with acquiring samyak dagdha lakshana. 3. Pashchat karma Ghritakumari Gar on Samyak Dagdha Vrana will be applied to get rid of instant burning sensation))
| | 2 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•रà¥à¤® | (Procedure Reference: Sushrut samhita, Kaviraj Vd. Ambikadattashastri, Sutrasthan adhyay 12/4. Chaukhambha publication, Reprint 2018. page no.51, Procedure details: (Procedure details: Follow up will be taken on Days 0, 7, 14, 21 & after 45 days if there is a recurrence. Agnikarma using suvarna shalaka tip, vidhi 1. Purva Karma Proper Informed consent of the patient will be taken. Part preperation. Instrument preparation. Position of the patient will be given. 2. Pradhan karma Agnikarma will be done with acquiring samyak dagdha lakshana. 3. Pashchat karma Ghritakumari Gar on Samyak Dagdha Vrana will be applied to get rid of instant burning sensation))
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 18-60 years of age.
2. Both sex male and female.
3. Patient having sign and symptoms of Manyastambha according to classics.
4. Patient willing and able to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Age group below 18years and above 60years.
2. Patient with history of direct and indirect trauma to spine.
3. Patient with other systemic disorder like CA spine, Bone cancer ,TB and fracture.
4. Patient with Cervical spondylolisthesis with neuro deficit.
5. Patient not willing to participate in trial. |
|
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Method of Generating Random Sequence
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Random Number Table |
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Method of Concealment
|
An Open list of random numbers |
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Blinding/Masking
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Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
The parameters will be noted down before and after treatment.
1. Ruja (Neck pain)
2. Shiroruja (Headache)
3. Sparshasahatva (Tenderness)
4. Manyastambha (Neck stiffness) |
0th, 7th, 14th and 21th and follow up will be taken on 45th day to observe recurrence. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1) No improvement - 0% relief in signs and symptoms.
2) Poor Improvement - 0%-25% relief in sign and symptoms.
3) Mild Improvement - 26%-50% relief in signs and symptoms.
4) Mod Improvement - 51%-75% relief in signs and symptoms.
5) Marked Improvement - 76%-100% signs and symptoms. |
0th, 7th, 14th and 21th and follow up will be taken on 45th day to observe recurrence. |
|
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Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
01/01/2025 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
The International Association for the Study of Pain (IASP) in its classification of chronic pain defines cervical spinal pain as pain perceived anywhere in the posterior region of the cervical spine, from the superior nuchal line to the first thoracic spinous process. This is clearly a topographic definition, and it states that neck pain is usually perceived posteriorly. This is consistent with patients of neck pain. Pain to the front of the cervical spine is usually described as pain in the throat and not as neck pain. Manyastambha is vataj nanatmaj vyadhi according to Acharya Sushruta. In manyastambh, there is involvement of vata and kapha dosha. The symptoms are Ruka (pain) stambha(restricted movement),gaurava4 Aacharya Sushruta has mentioned different methods of management of diseases such as Bheshaja karma, Yantra karma, Shastrakarma, and Agnikarma. ‘’ Agnikarma ‘’ has Evolved very Effectively through it. Agnikarma is an Ancient Medical Technique derived from the Indian System of Medicine (Ayurveda). It is a thermal and minimally Invasive Procedure that includes Controlled, pointed, and therapeutic burns over the regions that are tender or painful. Also, we can say that the disease once treated by Agnikarma does not reoccur. This procedure aims are manage various afflictions by inflicting burns on the tissue surface directly by using different materials known as ‘Dhahanopakarans’ ( tools of Cauterization).They are as follows, Pippali (Piper longum), Aja Shakrit (feces of Goat), Godanta (Teeth of Cow), Shara (Arrow), Shalaka (Probes), Varti(Wicks), Suryakanta (Variety of stone) etc. Likewise, for the diseases of muscles Loha (Iron), Swarna (Gold), Tamra (Copper) and Kamsya (bronze) are used. In deeper and stronger tissues like bones, ligaments, tendons, vessels etc., Madhu (Honey), Guda (Jaggery), Vasa(Fat), Ghrita(Ghee), Taila(Oil), Madhucchishta(Beeswax), etc. Agnikarma is used in the management of Manyastambha (Cervical Spondylitis). Here the heat, which is transferred to the skin acts by removing the obstruction in the Strotas (minute channel) and increases the blood circulation to the affected site. The rate of any metabolic activity is increased by a rise in temperature. From the therapeutic point of view with an appropriate rise in temperature, all cell activity increases, including dilatation of vessels, cell motility, synthesis and release of chemical mediators. More blood circulation, flushes away the inflammation and the patient gets relief from the symptoms. Afferent nerves stimulated by heat is having an analgesic effect by acting on the gate control mechanism. There are many more conditions which can be treated with Agnikarma, Pain management is one of them. Here We are using Agnikarma Yantra (Thermal cautery)with Suvarna and Rajat metal tips in pain management in Manyastambha (Cervical Spondylitis).
Why Agnikarma Yantra (Thermal Cautery)? Most physicians nowadays still use the traditional method for Agnikarma like heating metal Shalaka on flame, which is a lengthy process. It is not necessary the Shalaka temperature we got while heating always comes the same. With an thermal cautery machine, the tip of this modified Shalaka goes to the required temperature in a relatively very short time. In addition to this, we are using a thermostat8 with which we can manage the temperature accordingly for Samyak Dagdha. This way we can overcome these two problems while doing Agnikarma Chikitsa. |