| CTRI Number |
CTRI/2024/09/073170 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
28/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study To Evaluate The Efficacy Of Ayurvedic Tharapeutic In The Treatment Of Vatakantaka (Plantar Fasciitis) |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial To Evaluate The Efficacy Of Agnikarma By Using Gud (Jaggery) In The Management Of Vatakantaka WSR Plantar Fasciitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neha Hemant Patil |
| Designation |
PG Scholar |
| Affiliation |
MES Ayurved Mahavidyalaya Khed |
| Address |
Second floor, Shalyatantra department, PG Section, MES Ayurved Mahavidyalaya, Ghanekhunt Lote, Khed, Ratnagiri
Raigarh
MAHARASHTRA
415722
India |
| Phone |
8830935695 |
| Fax |
|
| Email |
patilnehu0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Devidas Pawar |
| Designation |
Assistant Professor |
| Affiliation |
MES Ayurved Mahavidyalaya Khed |
| Address |
Dept Of Shalyatantra, MES Ayurved Mahavidyalaya Khed
Raigarh
MAHARASHTRA
415722
India |
| Phone |
9822285836 |
| Fax |
|
| Email |
dr.ashok2575@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Devidas Pawar |
| Designation |
Assistant Professor |
| Affiliation |
MES Ayurved Mahavidyalaya Khed |
| Address |
Dept Of Shalyatantra, MES Ayurved Mahavidyalaya Khed
Raigarh
MAHARASHTRA
415722
India |
| Phone |
9822285836 |
| Fax |
|
| Email |
dr.ashok2575@yahoo.com |
|
|
Source of Monetary or Material Support
|
| MES Ayurved Mahavidyalaya & attached Parshuram Hospital & Research Center, Ghanekhunt Lote, Khed, Ratnagiri, Maharashtra, India - 415722 |
|
|
Primary Sponsor
|
| Name |
Neha Hemant Patil |
| Address |
MES Ayurved Mahavidyalaya Ghanekhunt Lote, Khed, Ratnagiri, Maharashtra, India - 415722. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neha Hemant Patil |
Parshuram Hospital |
Shalyatantra OPD NO - 1
Parshuram Hospital And Research Center Ghanekhunt Lote
Khed
Maharashtra
Raigarh
MAHARASHTRA |
8830935695
patilnehu0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MES ayurved mahavidyalaya ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: VATAKANTAKAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Lakshadi guggula, Reference: Bhaishajya ratnavali 49 chapter, 13-14, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(NA), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -koshnajala ), Additional Information: - | | 2 | Intervention Arm | Procedure | - | agnikarma, अगà¥à¤¨à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Sushruta Samhita Sutrasthana 12, Procedure details: Agnikarma By Using Gud Will Be Done On Plantar Aspect Of Heel. For 28 Days.
Follow up - 7,14,21,28 day)
(1) Medicine Name: Lakshadi Guggula, Reference: Bhaishajya Ratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2(), Frequency: , Duration: (2) Medicine Name: bd, Reference: 28 Days, Route: , Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: (), Frequency: , Duration: |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed Cases Of Vatakantaka With Symptoms Like Heel Pain, Difficulty In Walking, Tenderness
Selection Shall Be Irrespective Of Sex, Religion, Socioeconomical Status |
|
| ExclusionCriteria |
| Details |
1) Seriously Ill Patients
2) Patients With Diabetic Mellitus (200 mg/dl), Hypertension (140/100 mmHg), Malignancy, HIV, HBsAG, Cardiac Diseases, Anemia, Bleeding Disorders
3) Pregnant Women
4) Patient Having Pitta Prakriti
5) Patient With Fracture Of Ankle Joint |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Agnikarma by using Gud in the management of Vatakantaka W.S.R. Plantar Fasciitis |
28 days study with
Follow up on 7,14,21,28 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To study the etiopathogenesis of Vatakantaka W.S.R. to Plantar Fasciitis
2) To study the literature on agnikarma |
28 days study with
Follow up on 7th,14th,21st,28th day |
|
|
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)
|
17/09/2024 |
| 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="2"
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
|
Title - A Randomized Controlled Clinical Trial To Evaluate The Efficacy Of Agnikarma By Using Gud (Jaggery) In The Management Of Vatakantaka/ Plantar Fasciitis.
Null Hypothesis H0 - Agnikarma by Gud (Jaggery) not significantly effective in Vatakantaka.
Alternative Hypothesis H1 - Agnikarma by Gud (Jaggery) significantly effective in Vatakantaka.
Study design - Simple Randomized Controlled Clinical Trial.
Inclusive Criteria - 1) Diagnosed cases of Vatakantaka with symptoms like heel pain, difficulty in walking, tenderness. 2) Age group between 18 - 65 years. 3) Selection shall be irrespective of sex, religion, socioeconomical status.
Exclusive Criteria - 1) Patients with Diabetic mellitus (.200 mg/dl), Hypertension (140/100 mmHg), Malignancy, HIV, HBsAG, Cardiac Diseases, Anemia, Bleeding Disorders. 2) Pregnant Women 3) Patients with pitta prakriti 4) Patients having fracture of ankle joint
Sample size - Total 60 (30 for each group).
Patients coming in OPD & IPD of Shalyatantra department of our hospital with complaints of Vatakantaka (Plantar Fasciitis). Simple randomized sampling (Lottery method).
Group A - Agnikarma by using Gud (Jaggery).
Group B - Tab Lakshadi Guggula.
Total duration of drug administration is 28 days. The mode of drug administration will be by local route.
Follow Up - Follow up will be on 7,14,21,28 day.
Result - Result will be drawn as per assessment criteria & statistical analysis.
|