| CTRI Number |
CTRI/2024/04/066387 [Registered on: 26/04/2024] Trial Registered Prospectively |
| Last Modified On: |
29/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of Carpal tunnel syndrome with Murivenna bandage and Agnikarma |
|
Scientific Title of Study
|
Efficacy of Murivenna Bandage and Agnikarma in the Management of Snayugata Vata (Carpal tunnel syndrome)-An Open Labelled Randomised Comparative Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Esha Ebrahim |
| Designation |
PG Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar |
| Address |
Department of Shalya Tantra
Institute of Teaching and Research in Ayurveda, Jamnagar
Jamnagar GUJARAT 361008 India |
| Phone |
7025361628 |
| Fax |
|
| Email |
eshaebrahim96@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. T S Dudhamal |
| Designation |
H.O.D |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar |
| Address |
Department of Shalya Tantra
Institute of Teaching and Research in Ayurveda, Jamnagar
Jamnagar GUJARAT 361008 India |
| Phone |
9428671939 |
| Fax |
|
| Email |
drtsdudhamal@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr. T S Dudhamal |
| Designation |
H.O.D |
| Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar |
| Address |
Department of Shalya Tantra
Institute of Teaching and Research in Ayurveda, Jamnagar
Jamnagar GUJARAT 361008 India |
| Phone |
9428671939 |
| Fax |
|
| Email |
drtsdudhamal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda, Jamnagar |
|
|
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 |
|
|
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 Esha Ebrahim |
Institute of Teaching and Research in Ayurveda, Jamnagar |
Shalya Tantra OPD-02, Room no.104
Institute of Teaching and Research in Ayurveda, Jamnagar Jamnagar GUJARAT |
7025361628
eshaebrahim96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Institute of Teaching and Research in Ayurveda, Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G560||Carpal tunnel syndrome. Ayurveda Condition: SNAYUGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•रà¥à¤® | (Procedure Reference: Susruta Samhita Sutra Sthan adhyay 12, Procedure details: Agnikarma with Panchadhatu Shalaka will be done over tender points of hand including the wrist at the gap of 0.5 cm between two points of Dagdha. Procedure will be repeated at weekly interval for 30 days.)
| | 2 | Intervention Arm | Procedure | - | bandhanakarma, बनà¥à¤§à¤¨à¤•रà¥à¤® | (Procedure Reference: Susruta Samhita sutra sthan adhyay 18, Procedure details: bandhana (Bandage) will be done over the hand including the wrist after massaging with sufficient quantity of Murivenna taila. Approximately 3-5ml of Murivenna will be applied over the bandage at most tender area twice daily. Rebandage will be done at weekly interval for 30 days) (1) Medicine Name: Murivenna, Reference: The Ayurveda Formulatory of India, Part 3 First Edition,7:23, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria:
1. Patients suffering from Snayugata Vata (carpal tunnel syndrome)
2. Patients with age group 18-60 years irrespective of sex, religion, occupation, socio-economic status.
3. Patients of with/without Hypertension (BP below 140/90mmHg) and Diabetes mellitus (RBS below 150mg/dl). |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
1. Patients of with/without Hypertension (BP above 140/90mmHg) and has Diabetes mellitus with uncontrolled RBS (above 150mg/dl) due to vulnerability.
2. Patients with K/C/O paralysis, Parkinson’s disease, cardiac diseases, renal diseases, endocrine diseases, severe anemia, polyneuropathy and malignancy.
3. Pregnant and lactating females.
4. Patients contraindicated for Agnikarma and Bandhana as per classics. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Reduction of pain at hand
2. Reduction of numbness at hand
3. Reduction of tingling sensation at hand
|
day 1 and day 28
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Absence of recurrence in the follow up period. |
day 60 |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
17/06/2024 |
| Date of Study Completion (India) |
02/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
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
|
Brief Summary
Modification(s)
|
The clinical study titled “Efficacy of Murivenna Bandage and Agnikarma in the Management of Snayugata Vata (Carpal Tunnel Syndrome)” was an open-labelled, randomized comparative trial conducted on 30 patients diagnosed with Carpal Tunnel Syndrome (CTS). Participants were divided into two groups: Group A received Murivenna bandaging once weekly for four weeks, and Group B underwent Agnikarma at the tender points of the wrist for the same duration. The assessment included both subjective parameters (pain, Tinel’s sign, Phalen’s test, carpal compression test, and Boston CTS Questionnaire) and objective measures (nerve conduction study and wrist range of motion). Demographic analysis revealed a predominance of females (79%), mostly postmenopausal housewives from the middle socioeconomic class, with the majority aged between 51–60 years. The right hand was more frequently affected, and most patients had symptoms for less than six months with gradual onset.
Both Murivenna bandage and Agnikarma showed highly significant improvements (P < 0.001) in all subjective and objective parameters, including pain relief, CTS test outcomes, nerve conduction velocity, and wrist mobility. Comparative analysis between the two groups demonstrated no statistically significant difference in most parameters, indicating that both therapies were equally effective. However, the Functional Severity Scale of the Boston Questionnaire (P = 0.018) and palmar flexion range of motion (P = 0.023) showed significant differences, suggesting slightly superior functional improvement with Agnikarma. Both interventions provided relief from pain, tingling, and numbness, and improved wrist movements. Murivenna bandage was more effective in acute inflammatory and traumatic conditions, whereas Agnikarma produced better outcomes in chronic pain cases. Seasonal variation was also noted—Murivenna was more effective during the hot season, while Agnikarma showed better results in the cold season. Both treatments were cost-effective, minimally invasive, non-pharmacological, and suitable for outpatient management, with no adverse effects reported during the study or follow-up. Hence, the null hypothesis was accepted, confirming that Murivenna bandage and Agnikarma are equally effective in the symptomatic management of Snayugata Vata (Carpal Tunnel Syndrome). |