| CTRI Number |
CTRI/2025/02/080578 [Registered on: 14/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical trial to study effect of Asitakadi Churn in patients of Katigrah |
|
Scientific Title of Study
|
A Randomized controlled clinical trial to study the efficacy of Asitakadi Churn in the management of Katigrah with special reference to Lumbar 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 |
Akshara Vikas Suryawanshi |
| Designation |
PG Scholar |
| Affiliation |
Siddhakala Ayurveda Mahavidyalaya Sangamner |
| Address |
OPD number 1 Kayachikitsa department Siddhakala Ayurveda Mahavidyalaya Pimparne road Sangamner
Ahmadnagar Maharashtra
422605
India
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
7972534800 |
| Fax |
|
| Email |
aksharasuryawanshi1698@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Omkar Kortikar |
| Designation |
Head of department of Kayachikitsa |
| Affiliation |
Siddhakala Ayurveda Mahavidyalaya Sangamner |
| Address |
Kayachikitsa department Siddhakala Ayurveda Mahavidyalaya Pimparne road Sangamner
Ahmadnagar Maharashtra
422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9850218004 |
| Fax |
|
| Email |
omkar_kortikar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Omkar Kortikar |
| Designation |
Head of department of Kayachikitsa |
| Affiliation |
Siddhakala Ayurveda Mahavidyalaya Sangamner |
| Address |
Kayachikitsa department Siddhakala Ayurveda Mahavidyalaya Pimparne road Sangamner
Ahmadnagar Maharashtra
422605
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9850218004 |
| Fax |
|
| Email |
omkar_kortikar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Siddhakala Ayurveda Mahavidyalaya Pimparne road Sangamner 422605
Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Akshara Vikas Suryawanshi |
| Address |
Siddhakala Ayurveda Mahavidyalaya Sangamner Maharashtra
422605 |
| Type of Sponsor |
Other [Own] |
|
|
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 |
| Akshara Vikas Suryawanshi |
Siddhakala Ayurveda Mahavidyalaya Sangamner Pimparne road Maharashtra India 422605 |
Ground floor OPD number 1 Kayachikitsa department
Ahmadnagar
MAHARASHTRA |
7972534800
aksharasuryawanshi1698@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Board of Ayurved research and statistics committee of Siddhakala Ayurveda Mahavidyalaya Sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M858||Other specified disorders of bonedensity and structure. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Asitakadi Churn , Reference: Bhavprakash madhyamkhand Aamvaat , Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Ushnodak ), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Abhadi Churn , Reference: Yogratnakar Vatvyadhichikitsa , Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Ushnodak ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having signs and symptoms of Katigrah mentioned in the classic
Radiological degenerative changes in lumbar Spine
The Roland-Morris low back pain and disability questionnaire score more than or equal to 5
Patients of both sexes between 30-60 years of age |
|
| ExclusionCriteria |
| Details |
Patients age less than 30 years and more than 60 years
Patients having complicated diseases like fracture and of vertebrae spinal tumor malignancy and tuberculosis of spine
Patient with history of trauma to the spine and with marked deformities of spinal cord and disc prolapse
Known case of Ankylosing spondylosis Rheumatoid arthritis gouty Arthritis
Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of Asitakadi Churn particularly on the Roland and Morris low back pain and Disability questionnaire visual Analogue scale and clinical features of Katigrah with special reference to lumbar spondylosis
To compare the effect of Asitakadi Churn and Abhadi Churn |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To review and study the literature of Katigrah
To review and study the literature of lumbar spondylosis
Any new theoretical and practical concept if found will be noted down |
28 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
28/02/2025 |
| 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
|
This Study is Randomized open labelled Active Controlled trial 70 patients taken for study 35 patients in each group Comparing safety and efficacy of Asitakadi Churn with Ushnodak And Abhadi Churn with Ushnodak for 28 days in 70 patients of Katigrah |