| CTRI Number |
CTRI/2025/03/083716 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Ethnic Marma Therapy and Wet Cupping Therapy in Grivasandhigata Vata w.s.r. to Cervical Spondylosis |
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Scientific Title of Study
|
Efficacy of Ethnic Marma Therapy and Wet Cupping Therapy in Grivasandhigata Vata w.s.r. to Cervical Spondylosis – An open Labelled A Randomised Comparative Clinical Trial |
| 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 |
PAD PRABHA WEERANAYAKE |
| Designation |
PG STUDENT |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
Department of Shayla Tantra Institute of Teaching and Research in Ayurveda Jamnagar
Gujarat
361008
India
Jamnagar GUJARAT 361008 India |
| Phone |
6356250957 |
| Fax |
|
| Email |
prabha.weeranayake@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr P B JOSHI |
| Designation |
Reader |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
Department of Shayla Tantra Institute of Teaching and Research in Ayurveda Jamnagar
Gujarat
361008
Jamnagar GUJARAT 361008 India |
| Phone |
9427226504 |
| Fax |
|
| Email |
pbj@itra.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr P B JOSHI |
| Designation |
Reader |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
Department of Shayla Tantra Institute of Teaching and Research in Ayurveda Jamnagar
Gujarat
361008 Jamnagar GUJARAT 361008 India |
| Phone |
9427226504 |
| Fax |
|
| Email |
pbj@itra.edu.in |
|
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Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda ,Jamnagar ,Gujarat,India 361008 |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Institute of Teaching and Research in Ayurveda Jamnagar 361008 |
| Type of Sponsor |
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 Peduru Arachchige Don Prabha Weeranayake |
Institute of Teaching and Research in Ayurveda |
Institute of Teaching and Research in Ayurveda
Department of Shayla Tantra
OPD room112 Jamnagar GUJARAT |
6356250957
prabha.weeranayake@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Institute of Teaching and Research in Ayurveda |
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:M472||Other spondylosis with radiculopathy. Ayurveda Condition: GRIVASTAMBAH/GRIVAHUNDANAM (KEVALAVATA), (2) ICD-10 Condition:M488||Other specified spondylopathies. Ayurveda Condition: GRIVASTAMBAH/GRIVAHUNDANAM (KEVALAVATA), |
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | Wet Cupping | (Procedure Reference: , Procedure details: 1.Informed written consent will be taken from all patients
2. Before 1h of procedure, the patient will be advised to have Mudgayusha
3. Local Abhayang & Nadi swedana will be done prior to procedure
4. During the therapy, therapist has to continuously watch the facial expressions of the patient
5. Vitals should be checked before & after the therapy.
2. Procedure:
1. In the sitting position (semi-flexed neck), cups will be applied on the most painful points, & a negative pressure will created & maintained for 3–5 min.
2. Then, the cups will be released. Incisions will be made on the site by acupuncture needles of demarcated area of cups. Then, the cups will be reapplied on incision marked area, & negative pressure will be created)
| | 2 | Intervention Arm | Procedure | - | marmacikitsA, मर्मचिकित्सा | (Procedure Reference: Susrutha sareera chapter 06, Procedure details: The Marma Stimulation will be given at affected area of upper extremity
1.Krikatika Marma
2.Kshipra Marma
3.Kurpara Marma
4.Ani Marma
5.Urvi Marma
6.Ansa Marma
Each Marma will be stimulated 3-5 times in the same rhythm of inhale & exhale by digital pressure in one sitting. The rhythm of stimulation is same as the rhythm of respiration ,18 to 20 times per minute. The facial expression of the patient should be observed for pain, vertigo & fainting.
Each Marma point will be pressed for 20 times. Thus, one session of Marma Therapy will be carried out during the morning time. Once daily for 2 weeks)
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosed patients of Grivasandhi gate vats (cervical spondylosis) within the age group 20-60 years will be enrolled irrespective irrespective of sex , religion, occupation , socioeconomic status etc.
2.Patients who who are compulsory with Grivasandhi shoola ( cervical pain ) & Grivasandhi Stambha ( stiffness in cervical region).
3. Patients including Grivasandhi shoola & Grivasandhi Stambha & none of Grivasandhi shopha & Prasaran Akunchana Pavritti |
|
| ExclusionCriteria |
| Details |
1. Age below 20 years and above 60 years.
2. Patients with uncontrolled diabetes (RBS greater than 140mg/dl) and uncontrolled hypertension (BP greater than 160/90mmHg)
3. Tuberculosis of cervical spine & malignancy.
4. Patients with cervical rib, Fracture of Cervical Spine.
5. Other diseases like cardiac diseases, renal diseases and endocrine diseases, and severe Anaemia and immunosuppressive disorders, Serology Positive patients.
6. Pregnant and lactating women. |
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
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Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
1.Relief in pain and stiffness of Cervical Spondylosis.
2.Painless increased Angle to of the Movement ( AOM). |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cost effective
• Time saving
• Minimum facilities required
• Minimize side effects
• Non pharmacological |
4 weeks |
|
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Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
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Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
23/06/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
24/06/2026 |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
CONCLUSION
The present study demonstrates that both Ethnic Marma Therapy and Wet Cupping Therapy are effective in the management of Griva Sandhigata Vata with special reference to cervical spondylosis. Each therapy produced a highly significant reduction in Griva sandhi shoola and Griva sandhi stambha, a highly significant gain in all six directions of cervical movement, and a highly significant fall in the Neck Disability Index, every one of these changes carrying a p value of 0.001. Both groups moved from the range of moderate disability before treatment to the range of no or minimal disability after treatment, which indicates that the functional recovery obtained was not merely statistical but of a magnitude that patients would recognise in daily life.
On comparison between the two groups, not one of the fifteen outcome comparisons reached the conventional threshold of significance. The mean change in pain gave p = 0.374, stiffness gave p = 0.124, the Neck Disability Index gave p = 0.740, the associated complaints gave p values from 0.394 to 0.577 and the six cervical movements gave p values from 0.210 to 1.000. The null hypothesis, that Ethnic Marma Therapy and Wet Cupping Therapy are equally effective in the management of cervical spondylosis, is therefore accepted, and both alternative hypotheses are rejected. This acceptance should be read as an absence of demonstrated difference rather than as positive proof of equivalence, since fifteen patients in each group provide limited power to detect a modest difference. The consistent numerical advantage of Group A in the two subjective parameters, 68.24% against 57.54% in pain and 65.97% against 56.15% in stiffness, together with the p value of 0.124 for stiffness, represents a trend in favour of Ethnic Marma Therapy that a larger trial might resolve.
Since the two procedures deliver comparable benefit, the choice between them may reasonably rest on considerations other than efficacy, and here the difference in invasiveness becomes decisive. Ethnic Marma Therapy requires no instrument, breaks no skin and carries no risk of haemorrhage or infection, whereas wet cupping involves scarification with the attendant possibility of bleeding, skin discoloration, rash, transient increase in pain and local infection. Where two treatments are equally effective, the less invasive is ordinarily to be preferred, and this consideration weighs particularly in elderly patients, in those receiving anticoagulant therapy and in those with impaired glycaemic control. Neither therapy required any internal medication, which is a further advantage in patients for whom the prolonged use of non-steroidal anti-inflammatory drugs is hazardous.
It is concluded that Ethnic Marma Therapy deserves a wider place in the conservative management of Griva Sandhigata Vata than it presently occupies, and that Wet Cupping Therapy remains a reasonable alternative where local evacuation is specifically indicated and the contraindications to scarification have been excluded. The findings are limited by the small sample, the open-label design, the absence of a sham-controlled arm and the lack of long-term follow-up, and they should therefore be confirmed by an adequately powered multicentric trial incorporating a placebo arm and a follow-up period of not less than six months, so that the durability of the response and the rate of recurrence can also be established.
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