| CTRI Number |
CTRI/2025/03/082849 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
19/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Other (Specify) [Curative] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on Efficacy of Marma therapy and shringavcharan in Manayastambha |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF MARMA STIMULATION BY HAND AND SHRINGAVCHARAN (WET CUPPING) IN MANYASTAMBHA (CERVICAL SPONDYLOSIS) |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swati Raheja |
| Designation |
MS Scholar |
| Affiliation |
Institute for ayurveda studies and research |
| Address |
PG Department of Shalya tantra, Institute for ayurveda studies and research, Shri Krishna Ayush University Sector 8, Umri road kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9996442762 |
| Fax |
|
| Email |
swatiraheja2012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Swati Raheja |
| Designation |
MS Scholar |
| Affiliation |
Institute for ayurveda studies and research |
| Address |
PG Department of Shalya tantra, Institute for ayurveda studies and research, Shri Krishna Ayush University Sector 8, Umri road kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9996442762 |
| Fax |
|
| Email |
swatiraheja2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swati Raheja |
| Designation |
MS Scholar |
| Affiliation |
Institute for ayurveda studies and research |
| Address |
PG Department of Shalya tantra, Institute for ayurveda studies and research, Shri Krishna Ayush University Sector 8, Umri road kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9996442762 |
| Fax |
|
| Email |
swatiraheja2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for ayurveda studies and research ,Shri Krishna Ayush University Sector 8 Umri road ,Kurukshetra |
|
|
Primary Sponsor
|
| Name |
Institute for ayurveda studies and research |
| Address |
Institute for ayurveda studies and research, Shri Krishna Ayush University Sector 8, Umri road kurukshetra 136118 |
| Type of Sponsor |
Government 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 Anamika |
Institute for ayurveda studies and research |
Room no 103,PG department of Shalya Tantra Institute for ayurveda studies and research, Shri Krishna Ayush University Sector 8, Umri road kurukshetra
Kurukshetra
HARYANA |
9896873083
academicanamika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M953||Acquired deformity of neck. Ayurveda Condition: MANYASTAMBAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | SrRu~ggAvacaraNam nृंगावचरणम | (Procedure Reference: sushruta sutra 13/5, Procedure details: Procedure Reference: Sushruta sutrasthan 13/5, Procedure details: Purva karma- Written informed consent will be obtained from all participants as it is a critical component of any surgical or para-surgical procedure. The patient will be positioned in prone position comfortably on the examination table to ensure relaxation & ease during the procedure. The treatment area will be thoroughly cleaned with a Betadine solution to ensure aseptic conditions before the application of cupping therapy. PRADHAN KARMA – First prachan karma with the help of blade no 12 Then a cotton ball will be soaked in nearly pure alcohol, clamp it with forceps, ignite it with a match stick or lighter, place it into the cup & quickly remove it. Immediately the cup will be placed on the body i.e. on both the sides of vertebral column nape of neck & posterior aspect of the region between clavicle & Scapula blade, creating negative pressure that pulls the skin up. The cups will be removed after 2-3 minutes. PASCHAT KARMA – After the procedure Jatayadi Tail will be applied to prevent any possible infection. Patient will be advised not to take shower or bath should be taken within 12 hours after cupping. Patient will be advised to take nutritious liquids should be consumed after cupping. Follow-ups will be conducted on the 28th, 35th, 42th, days after starting the treatment.)
| | 2 | Intervention Arm | Procedure | - | marmacikitsA, मर्मचिकित्सा | (Procedure Reference: sushruta sharira chapter 6, Procedure details: Procedure Reference: Sushruta sharir 6 Procedure details: Poorva Karma: Written informed consent will be taken as it is mandatory part of any surgical or parasurgical procedure. Patients will be made to sit comfortably on stool. Pradhan Karma: Marma points will be stimulated by hand on both sides one by one. Marma sites are stimulated bilaterally. Following Marmas will be stimulated Each Marma will be stimulated 20 times by digital pressure in one sitting. The rhythm of stimulation will be synchronous with the rhythm of cardiac cycle i.e. approx. 0.8/sec or 72 beats / min. Whole procedure will be completed in approximately 10 min. The treatment will follow for 21 sittings on daily basis for three weeks. The progress will be daily noted & statistically evaluated Paschat Karma Patient will be advised rest after procedure completion for atleast 30 minutes after that general assessment of patient condition should be done.)
|
|
|
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Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed and confirm case of Manyastambha .
Patient having symptoms for more than 6 months and less than 2 years.
Willingness of patient for study. |
|
| ExclusionCriteria |
| Details |
Age below 25 years and above 45 years.
Patients of cervical fracture within last six months.
Patients having any surgical procedure of cervical vertebra in last one year.
Patients suffering from uncontrolled Diabetes Mellitus and hypertension
Patient suffering from localized skin infection
Pregnant women and lactating mothers
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the comparative changes in pain levels, measured by the Visual Analog Scale (VAS), and in the range of motion, assessed using a goniometer. |
21 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Symptoms of Manyastambha and elevating the standard of living the life of patients |
21days |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/04/2025 |
| 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="0"
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
|
Manyastambha is a vataj nanatmaj vyadhi mentioned in Charak samhita. It is caused due to kaph avrit vata and doshas get aggravated due to wrong sleeping , diwaspana, continously watching downward or upwards for a longer period of time causing over streching of neck muscles. This disorder presents with a notable loss of flexibility in the cervical region, which impairs the normal movement of neck. This can be closely compared to Cervical Spondylosis due to their similar symptomalogy , particularly the pain and stiffness in the nape of neck. Cervical spondylosis has become one of the prevelant disorder affecting the cervical spine . It significantly impacts an individual quality of life. Marma sharir is a a singificant aspect of Ayurveda, the traditional Indian symtem pf medicine . It is considered as Shalya ardha .Acharya Sushruta had described Marma from the surgical point of view, him being focused on surgeries but now a days Marma are being extensively used for therapeutic purpose specially for musculoskeltal pain. It focuses on the manipulation of specific vital points on the body Cupping Therapy is an ancient therapeutic practice . This alternative treatment involves placing cups on the skin to create suction, which purposly helps to moblize flow ,alleviate pain and promote healing The other treatment such as analgesics, anti inflammatory drugs, physiotherapy has its cons on form of complications like reccurence, permanent loss of working capabilities are a costly affair .There is a need for ongoing reseach to optimise management stratgies & fills due gap of pharmacological and surgical intervention . |