| CTRI Number |
CTRI/2024/07/070867 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between efficiency of agnikaram and Dry cupping in the management of lower back pain |
|
Scientific Title of Study
|
A Comparative Random Clinical Trial On Efficacy of Agnikaram and Dry Cupping In The Management Of Katishoola W.S.R. To Lower Back Pain |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NEHA KUMAWAT |
| Designation |
PG Scholar |
| Affiliation |
Institute For Ayurved Studies And Research,Faculty Of Ayurveda |
| Address |
PG Department Of Shalya Tantra , Institute For Ayurvedic Studies & Research ,Faculty Of Auyrved, Sector 8 Umri Road Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
9057876554 |
| Fax |
|
| Email |
dr.nehakumawat96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Anamika |
| Designation |
Assistant Professor |
| Affiliation |
Institute For Ayurved Studies And Research,Faculty Of Ayurveda |
| Address |
Room no. 103 PG Department Of Shalya Tantra , Institute For Ayurvedic Studies And Research ,Faculty Of Auyrved Sector 8 Umri Road Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
9896873083 |
| Fax |
|
| Email |
dranamikashalyavida@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
NEHA KUMAWAT |
| Designation |
MS Scholar |
| Affiliation |
Institute For Ayurved Studies And Research,Faculty Of Ayurveda |
| Address |
PG Department Of Shalya Tantra , Institute For Ayurvedic Studies And Research ,Faculty Of Auyrved Sector 8 Umri Road Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
9057876554 |
| Fax |
|
| Email |
dr.nehakumawat96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies & Research, Faculty of Ayurved,Umri road sector 8 ,kurukshetra, Haryana 136118 |
|
|
Primary Sponsor
|
| Name |
Institute For Ayurved Studies and Research Faculty Of Ayurved |
| Address |
Institute For Ayurved Studies and Research Faculty Of Ayurved sector 8 umri road kurukshetra Haryana 136118 |
| Type of Sponsor |
Government medical college |
|
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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 Anamika |
Institute for Ayurved Studies & Research, Faculty of Ayurved |
Room no. 103 PG department of Shalya tantra, Institute for Ayurved Studies & Research, Faculty of Ayurved Umri road sector 8 kurukshetra Haryana 136118
Kurukshetra
HARYANA |
9896873083
dranamikashalyavida@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, shree Krishna ayush University kurukshetra Haryana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M545||Low back pain. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | alAbU-avacaraNam, अलाबू-अवच रणमॠ| (Procedure Reference: Su.su.13, Procedure details: Dry cupping is correlated with alabu avcharan.
Poorva karma
1.Written informed consent will be taken.
2.Patient will be made to lie down comfortably on table.
3.Wounds, raised local temperature, sensitivity of skin, any damages will be checked.
4.The surface will be cleaned with betadine solution before cupping therapy.
Pradhan karma
1.A cotton ball will be soaked in pure alcohol, and then it will be clamped by a pair of forcepsand lit through a matchstick or lighter and placed into the cup and quickly removed.
2.The cup is then quickly placed onto the body and the negative pressure will suck the skin - up .
3.After 2-3 minutes cups will be removed.
Pashchat karma
1.After the procedure, jatayadi tail will be applied to prevent infection.
2. Patient will be advised not to take shower or bath within 12 hrs after cupping.3.Patient will be advised to take adequate nutritious liquid)
| | 2 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushrut samhita sutra sthan 12 , Procedure details: Agnikarma:-Agnikarma is divided into three phases according to trividha karma.
Poorva karma,Pradhan karma,Pashchat karma
Poorva karam-Written informed consent will be taken as it mandatory part of any surgical or parasurgical procedure.Patients make to sit comfortably on stool. Preparation of the part:Neck area is cleaned with distilled water and wipped with dry sterillized gauze piece.Drape the patient with sterile sheet.Most tender site will be assessed for Agnikaram . Panchdhatu shalaka placed on burner till get red hot.
Pradhan karma:-Bindu type of agnikaram will be done by red hot panchdhatu shalaka till the lakshan of samyak twakdagdha.
Pashchat karma:-Immediately after the Agnikaram, Aloevera pulp and turmeric powder will be applied on the site of Agnikaram to avoid burning sensation and scar formation .
Patient is advised to avoid dietic regimen which aggravates vata dosh.
Shedule:- There will be 3 sittings of Agnikaram that is advised weekly (based))
|
|
|
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosed and confirmed case of lower back pain, as per case report form and the basis of the sign and symptoms.
2.Patient between the ages of 20-70 years.
3.Patients of either gender, religion, occupation.
4.Patients who will be willing for the treatment. |
|
| ExclusionCriteria |
| Details |
1.Pregnant women
2.Patient suffering from potts spine, metastatic disease of spine, uncontrolled hypertension.
3.Patient with condition mentioned under contraindications for Agnikaram and Dry cupping in Sushruta samhita.
-Patient with systemic diseases like uncontrolled diabetes. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To give symptomatic relief in pain |
At baseline, 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Objective criteria -Lumbar spine range of movement
Subjective criteria -Pain, Disability |
At baseline, 8 weeks
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
24/07/2024 |
| 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 Yet Recruiting |
| 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
|
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Brief Summary
|
The back pain has become one of the leading causes of disability in our society and cost of the treatment has been increasing progressively each year without any obvious effect on the frequency and severity of condition. Katishoola that occurs due to vitiated Vata Dosha can be cured by Snehan, Swedan, Agnikarma, Basti , Abhyanga , Dry Cupping , Wet Cupping etc. The Agnikarma is established method but according to Acharya Sushurta there are some limitations of Agnikarma as Agni karma is contraindicated in many of the patients eg. Pitta Prakrati ,Baal, Vridha , Bheeru etc. According to Acharya Sushruta Agni karma is contraindicated in "Sharad Ritu" and "Grishma Ritu". Here lies the scope of cupping therapy, it can be done on Pittaj Prakrati and Raktaj Prakrati patients and hence we can provide an alternative therapy for these patients. Cupping therapy can be performed in all "Ritu". Agnikarma is mainly localized therapy but Cupping therapy includes wide area which may help the patient in relief of symptoms perhaps in better way. This study mainly will helps us to find which procedure is easy, safe, and comfortable to patient, cost effective and their efficacy.
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