| CTRI Number |
CTRI/2025/04/085114 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
11/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative clinical study to evaluate the efficacy of Vyoshadhya gutika Koladi lepa and Trisneh tail in the management of Sandhigata vata w.s.r. Osteoarthritis |
|
Scientific Title of Study
|
A comparative clinical study of Vyoshadhya Gutika Koladi Lepa and Trisneh Tail in the management of santhigata Vata w.s.r. to Osteoarthritis |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ruchi Tirkey |
| Designation |
PG Scholar Department of Kayachikitsa |
| Affiliation |
Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh |
| Address |
OPD N0. 2 and 18 Department of Kayachikitsa, Shri Narayan Prasad Awasthi Government Ayurved College Raipur Chhattisgarh 492010 India
Raipur CHHATTISGARH 492010 India |
| Phone |
7987037224 |
| Fax |
|
| Email |
ruchitirkey24011991@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Aruna Ojha |
| Designation |
Proffesor in Department of kayachikitsa |
| Affiliation |
Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh |
| Address |
OPD No. 2 and 18 Department of kayachikitsa, shri Narayna Prasad Awasthi Govt. Ayurved College, Raipur Chhatisgarh 492010 India
Raipur CHHATTISGARH 492010 India |
| Phone |
9424401858 |
| Fax |
|
| Email |
arunaojha90@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Arunima verma |
| Designation |
Reader in Department of Kayachikitsa |
| Affiliation |
Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh |
| Address |
OPD No. 2 and 18 Department of Kayachikitsa Shri Narayna Prasad Awasthi Government Ayurved college Raipur Chhattisgarh 492010 India
Raipur CHHATTISGARH 492010 India |
| Phone |
9907424440 |
| Fax |
|
| Email |
arunima.ayu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of kayachikitsa shri narayan prasad awasthi govt ayurveda college Raipur chhattisgarh 492010 |
|
|
Primary Sponsor
|
| Name |
Department of Kayachikitsa Shri Narayan Prasad Awasthi Government Ayurveda College Raipur C.G |
| Address |
Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh Pin 492010 India |
| Type of Sponsor |
Other [Government Ayurveda College Raipur Chhattisgarh ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Kayachikitsa Shri Narayan Prasad Awasthi Government Ayurveda College Raipur CG |
Shri Narayan Prasad Awasthi Government Ayurveda College Raipur Chhattisgarh Pin 492010 India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ruchi Tirkey |
Shri Narayan Prasad Awasthi Government Ayurveda College Raipur |
opd no2 and 18 ipd in the department of kayachikitsa at shri Narayan Prasad Awasthi Government Ayurveda College Raipur CHHATISGARH 492010 Raipur CHHATTISGARH |
7987037224
ruchitirkey24011991@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE GOVERNMENT AYURVED COLLEGE RAIPUR (C.G.) 492010 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, (2) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, (3) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, (4) ICD-10 Condition:M199||Osteoarthritis, unspecified site. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vyoshadhya Gutika, Reference: Gadanigraha Khanda 1, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 650(mg), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Sukhoshna jala), Additional Information: - | | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Charak Samhita , Procedure details: By taking Koladi Lepa in powder form & applied it after mixing with mild hot Kanji. Duration - 1 time in a day for 1-2 hours) (1) Medicine Name: Koladi Lepa, Reference: Charak Samhita, Route: Topical, Dosage Form: Churna/ Powder, Dose: 20(g), Frequency: od, Duration: 60 Days | | 3 | Comparator Arm | Procedure | - | jAnu-bastiH, जानु-बस्तिः | (Procedure Reference: Abhinava Chintamani, Procedure details: During this procedure creating a reservoir around the knee joint using dough made from Black gram flour then pour warm medicated oil which is Trisneh Tail into the reservoir, it nourishes the knee joint & resolves the disease called Sandhivata. Duration - 1 time in a day for 30-45 min. ) (1) Medicine Name: Koladi Lepa, Reference: Charaka Samhita, Route: Topical, Dosage Form: Churna/ Powder, Dose: 20(g), Frequency: od, Duration: 60 Days |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
It based on clinical signs and symptoms mentioned in ayurveda classics and modern literature, especially Joint pain, morning stiffness in joints, swelling in joints with the help of Scoring vas scale visual analog scale WOMAC index |
|
| ExclusionCriteria |
| Details |
1. Patients below 30 years and above 70 years of age will not be taken.
2. Patients diagnosed with Serious heart disease.
3. Blood related disorders.
4. Skin cancer.
5. Acute stage of diabetes.
6. Emergency fracture in the affected joint.
7. Pregnant and lactating women.
8. History of hypersensitivity to any of the trials and their ingredients.
9. Patients with serious kidney related problems.
10. Obese patients and if there is any kind of infection in the joint.
|
|
|
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 |
| reduce the symptom of sandhigata vata especially pain ,swelling,and stiffness(sandhigata vata) |
reduce the symptom of sandhigata vata 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improve the quality of life |
90 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 |
|
Date of First Enrollment (India)
|
11/05/2025 |
| 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
|
: According to acharya charak vata dosha increases, due to quality vata dries up the When the its rough shlesak kafa present in the Joint, due to which the normal functioning of the Joints is affected for reason. the this Sandigata vata diseases Caused by vata. they can be classified under the following headings. pratyatma lakshana. Sandh Sandhi Shoola, Sandhi shotha, prasarna Akunchna vedna and stabdhata. the similarity of sandhigata vata is with Osteoarthritis described in morden medical science Osteoarthritis is a degenerative Joint dise ase in which the tissues in the most common the joint break down Primary symptoms of OA are joint inflammation, pain, loss of function, and pain during flexion extension of knee joint. For the present study, on SANDHIGATA VATA as shaman therapy, the medicine I choose is a suitable natural product that will make it possible for patients to live a high quality of life along with reducing the specific symptoms of pain, swelling & stiffness. These medicines have properties of deepan.pachan, shoolahar & shothahar without any side effects in our textes. Considering the magnitude of sandhigata vata , I am doing a clinical & comparative study of vyoshadhya gutika koladi lepa and Trisneh tail in the management of sandhigata vata the volunteers will be informed about the study protocol, willing participants will be randomly selected as per the coin method. clinical research format will be prepared and validated before the study approval will be taken from the IEC of the NPA government Ayurved college and hospital, Raipur C.G.and CTRI registration will be done, after selection, each participant will be tasted individually and selected according to the selection criteria Sixty patients of sandhigata vata will be selected from Kayachikitsa OPD and IPD Shri NPA government Ayurveda college and hospital, Raipur C.G. The case selection was in regards to age, sex, occupation, and socioeconomic conditions. Both acute and chronic phases of sandhigata vata patients were taken for the study, following the CCRS criteria for diagnosing OA in modern medicine and the clinical features of sandhigata vata described in charka samhita . The present study is a single-center, open-labeled randomized (coin method) clinical trial. A total of 60 clinically diagnosed and registered patients of sandhigata vata were divided randomly by coin method into two groups. Each group will have 30 patients. Group A: 30 clinically diagnosed patients of sandhigata vata will be treated with vyoshadhya gutika two tablets(each 650 mg) three times in a day with lukewarm water before meal for 90 days along with koladi lepa every single day one time in a day with the help of kanji Group B: 30 clinically diagnosed patients of sandhigata vata were treated with vyoshadhya gutika two tablet (each650mg) three times in a day with lukewarm water befor meal for 90days along with Trisneh tail for janu vasti as per requirement for 10days after that I will give tail for abyangarth . Sixty patients of sandhigata vata will be selected from Kayachikitsa OPD and IPD Shrihri NPA government Ayurved college and hospital, Raipur C.G. The case selection was in regards to age, sex, occupation, and socioeconomic conditions. Both acute and chronic phases of sandhigata vata patients were taken for the study, following the CCRS criteria for diagnosing OA in modern medicine and the clinical features of sandhigata vata described in charka samhita . The present study is a single-center, open-labeled randomized (coin method) clinical trial. A total of 60 clinically diagnosed and registered patients of sandhigata vata were divided randomly by coin method into two groups. Each group will have 30 patients. Group A: 30 clinically diagnosed patients of sandhigata vata will be treated with vyoshadhya gutika two tablets(each 650 mg) three times in a day with lukewarm water before meal for 90 days along with koladi lepa every single day one time in a day with the help of kanji Group B: 30 clinically diagnosed patients of sandhigata vata were treated with vyoshadhya gutika two tablet (each650mg) three times in a day with lukewarm water befor meal for 90days along with Trisneh tail for janu vasti as per requirement for 10days after that I will give tail for abyangarth . |