| CTRI Number |
CTRI/2023/09/058079 [Registered on: 27/09/2023] Trial Registered Prospectively |
| Last Modified On: |
25/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To compare the role of Vishamushtyadi Vati, Erandmuladi Yoga Basti and Agnikarma in Gridhrasi (Sciatica) |
|
Scientific Title of Study
|
Clinical evaluation on the efficacy of Vishamushtyadi Vati, Erandmuladi Yoga Basti and Agnikarma in Gridhrasi with special reference to Sciatica |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Parnika Shukla |
| Designation |
Junior Resident |
| Affiliation |
Faculty of Ayurveda IMS BHU Varanasi |
| Address |
Department of Kayachikitsa Faculty of Ayurveda IMS BHU Lanka Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9721049341 |
| Fax |
|
| Email |
parnikashukla26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Sunanda R Pedhekar |
| Designation |
Professor |
| Affiliation |
Faculty of Ayurveda IMS BHU |
| Address |
Department of Kayachikitsa Faculty of Ayurveda IMS BHU Lanka Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9423241800 |
| Fax |
|
| Email |
drsrpedhekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Parnika Shukla |
| Designation |
Junior Resident |
| Affiliation |
Faculty of Ayurveda, IMS-BHU |
| Address |
Department of Kayachikitsa Faculty of Ayurveda IMS BHU Lanka Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9721049341 |
| Fax |
|
| Email |
parnikashukla26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Kayachikitsa, IMS BHU |
|
|
Primary Sponsor
|
| Name |
Parnika Shukla |
| Address |
Department of Kayachikitsa Faculty of Ayurveda IMS BHU Lanka Varanasi |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Parnika Shukla |
Sir Sunderlal Hospital, IMS BHU |
Kayachikitsa OPD and IPD, Ayurveda Wing, Sir Sunderlal Hospital, IMS BHU Varanasi, Uttar Pradesh, 221005
Varanasi
UTTAR PRADESH |
9721049341
parnikashukla26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M543||Sciatica. Ayurveda Condition: GRUDHRASI, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vishamushtyadi Vati, Reference: Siddha Bhaishaj Mani Mala, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Ghrita), Additional Information: - | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤®/वसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Ashtang Hridaya, Procedure details: Anuvasana and Niruha Basti in form of Yoga Basti
Once per day)
(1) Medicine Name: Erandmuladi Kwath, Reference: Ashtang Hridaya, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 445(ml), Frequency: od, Duration: 8 Days | | 3 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Chakrapani, Procedure details: Agnikarma over Achilles tendon once a week for 28 days)
|
|
|
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed cases of Gridhrasi with symptoms(either vataj or vata kaphaj)
2. SLR i.e. straight leg raising test positive
3. Patients of age group between 30 to 60 years.
4. Sex - Either sex, race, caste, religion |
|
| ExclusionCriteria |
| Details |
1. Known cases of uncontrolled diabetes mellitus, hypertension, tuberculosis of spine, fracture related to spine or malignancy of spine.
2. Known case of Cardiac diseases (ischemic heart disease, trauma, coronary artery disease, myocardial infarction etc.)
3. Pregnancy
4. Patients who have completed participation in any other
clinical trial during the past 6 months.
5. Age below 30 and above 60 years
6. Monoplegia, Paraplegia |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain
Stiffness
Aversion to food |
At duration of 15 days, 30 days & 45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pricking sensation
Twitching
Drowsiness
Heaviness |
At duration of 15 days, 30 days & 45 days |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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 3 |
|
Date of First Enrollment (India)
|
25/10/2023 |
| 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="0"
Months="1"
Days="15" |
|
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
|
This study is about comparative effect of Vishmushtyadi Vati, Erandmuladi Yoga Basti and Agnikarma. Vishmushtyadi Vati, Erandmuladi Yoga Basti and Agnikarma as described in Ayurvedic classics has very effective role in management of Gridhrasi (Sciatica). This study is to assess the comparative role of Vishmushtyadi Vati, Erandmuladi Yoga Basti and Agnikarma in the management of Gridhrasi (Sciatica). |