| CTRI Number |
CTRI/2023/12/060834 [Registered on: 27/12/2023] Trial Registered Prospectively |
| Last Modified On: |
04/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative Clinical Efficacy of Trayodashang Guggul and Asitaka Churna Vati in the Management of Katigraha (Stiffness in Lumbar Region) |
|
Scientific Title of Study
|
Evaluation of Comparative Efficacy of Trayodashang Guggul Versus Asitaka Churna Vati in the Management of Katigraha (Stiffness in Lumbar Region)-RCT |
| 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 Bhishmani Tarare |
| Designation |
PG Scholar |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Room no 30 Department of Kaychikitsa Mahatma Gandhi Ayurved
College Hospital and Research Centre Salod Wardha Maharashtra
442001 India
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
7666155486 |
| Fax |
|
| Email |
bhishmanitarare9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sadhana Misar(Wajpeyi) |
| Designation |
Professor and HOD |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Room no 30 Department of Kayachikitsa Mahatma Gandhi Ayurved
College Hospital and Research Centre Salod Wardha Maharashtra
442001 India
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9763732083 |
| Fax |
|
| Email |
sadhanamisar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhishmani Tarare |
| Designation |
PG Scholar |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Room no 30 Department of Kaychikitsa Mahatma Gandhi Ayurved
College Hospital and Research Centre Salod Wardha Maharashtra
442001 India
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
7666155486 |
| Fax |
|
| Email |
bhishmanitarare9@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha |
|
|
Primary Sponsor
|
| Name |
Dr Bhishmani Tarare |
| Address |
Mahtama Gandhi Ayurved College Hospital and Research Centre salod Hirapur wardha Maharashtra |
| 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 |
| Dr Bhishmani Tarare |
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Hirapur Wardha |
OPD and IPD of Department of Kayachikitsa MGACHRC and AVBRH Wardha
Wardha
MAHARASHTRA |
7666155486
bhishmanitarare9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurved College Hospital and Research Centre Institutional Ethical 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: Katigraha, (2) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: VATAVYADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Asitaka Churna Vati, Reference: Bhavaprakash, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Luke Warm Water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Trayodashang Guggul, Reference: Gadanigraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Luke Warm Water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Patient willing to participate with written informed consent.
• Patients aged between 30-60 years of either sex.
• Patients having cardinal signs and symptoms of Katigraha |
|
| ExclusionCriteria |
| Details |
• Cases of traumatic injury
• Known cases of bone tumor, Ca spine, tuberculosis of vertebral column, fibrosis of sacral ligament and protruded inter vertebral disc.
• Patients suffering from systemic diseases like renal diseases, cancer, tuberculosis and other major health problems.
• Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain and stiffness in lumbar region |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in day to day activities |
30 days |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/01/2024 |
| 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
|
The volunteers will be informed about the study protocol. Willing participant will be randomly selected as per computer generated table. Clinical research will be prepared and validated. Prior to the study approval will be taken from IEC, MGACHRC, Salod (H), Wardha and CTRI Registration will be done. After selection, each participant will be tested individually and selected according to selection criteria. They will be divided into two groups as the trial is parallel group, randomized open clinical, standard controlled trial. It will include 30 days treatment period and follow up
|