| CTRI Number |
CTRI/2024/10/075832 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
16/10/2024 |
| 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
|
To study effect of medicated Panchatikta ghee after fasting in Aamvaat |
|
Scientific Title of Study
|
A Randomised Controlled Clinical Study Of Efficacy Of Langhanottar Panchatikta Ghrita Snehpana In Aamvata With Special Reference To Rheumatoid Arthritis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Ramrao Dhone |
| Designation |
PG scholar |
| Affiliation |
Government Ayurvedic College, Vazirabad, Nanded |
| Address |
Department of Kayachikitsa, Government Ayurvedic College, vazirabad,Nanded
PG hostel,Government Ayurvedic College, vazirabad, Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9146933776 |
| Fax |
|
| Email |
poojadhone8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVishwas E Gogate |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurvedic College and hospital,Nanded |
| Address |
Department of Kayachikitsa, Government Ayurvedic College, vazirabad,Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9422214311 |
| Fax |
|
| Email |
vgogate21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Drvishwas E Gogate |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurvedic College and hospital, Nanded |
| Address |
Department of Kayachikitsa, Government Ayurvedic College,vazirabad, Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9422214311 |
| Fax |
|
| Email |
vgogate21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital,Vazirabad Nanded Dist.Nanded 431601 ,India |
|
|
Primary Sponsor
|
| Name |
Pooja Ramrao Dhone |
| Address |
Department of Kayachikitsa,
Government Ayurvedic College and hospital, vazirabad, Nanded 431601,India
Nanded 431601 ,India |
| 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 Pooja Ramrao Dhone |
Government Ayurvedic College and hospital, Nanded |
Department of Kayachikitsa, Government Ayurvedic College, vazirabad,Nanded
Nanded
MAHARASHTRA |
9146933776
poojadhone8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,Govt.Ayurved College and Hospital, Nanded |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M069||Rheumatoid arthritis, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Langhanottar snehapana | (Procedure Reference: Bhavprakash madhyam khanda adhyay 26, Procedure details: Langhana for 3-7days days as per attentment of samyak Langhana lakshanas followed by snehapana for 7days with panchatikta ghrita 10ml BD )
(1) Medicine Name: Panchatikta Ghrita , Reference: Yog ratnakar kushtha chikitsa adhyay , Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Duration: 7 Days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Simhanada guggulu , Reference: Bhaishajya ratnavali Aamvatadhikar adhyay , Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -sukoshna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients fulfilling the diagnostic criteria of Aamvata and Rheumatoid Arthritis will be included.
Patients between 18-60 years of age group.
Patient of either sex.
Patients having history of the disease for not more than 2 years and having acute attack in last 1 month. |
|
| ExclusionCriteria |
| Details |
Patients having history of the disease for more than 2 years.
Severe ankylosed joints.
Patients who are steroid dependent.
Patient suffering from Systematic severe illness.
Pregnant and lactating women.
Pregnant and lactating woman. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the relief in signs and symptoms of Aamvata by Langhanottar Snehpana Upkrama by using Das 28 Score.
To study the changes in ESR levels by Langhanottar Snehpana Upkrama.
|
Langhana for 3-7days as per attentment of samyak Langhana symptoms followed by Snehpana for 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study Langhanottar Niramavastha Lakshanas. |
3-7days as per attentment of samyak Langhana lakshanas |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
05/11/2024 |
| 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
|
This is randomized open labelled controlled, clinical study of effect of Langhana for 3-7 days as per attentment of samyak Langhana lakshanas followed by snehapana with panchatikta ghrita 10ml BD for 7 days in rasayankala . Simhanada guggulu (500mg) BD for 15 days will be given in control group . This study is conducted as PG course at single centre. The primary outcome is to evaluate the effect of langhanottar Snehapana karma in Aamvata with special reference to Rheumatoid Arthritis.
Outcome of the Study will be assesed on following criteria - For subjective parameter: symptoms of Aamvata were graded on five point scale with Scoring 0 to 4. For objective parameter: DAS 28 score ,ESR and CRP will be assessed before and after treatment. |