| CTRI Number |
CTRI/2025/02/081209 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
22/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
LANGALI GUTIKA AND DHATURADYA TAILA TREATMENT IN VATARAKTA(Gout). |
|
Scientific Title of Study
|
A CLINICAL STUDY TO EVALUATE THE EFFICACY OF LANGALI GUTIKA AND DHATURADYA TAILA IN THE MANAGEMENT OF VATARAKTA |
| 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 Jagrati Ahirwar |
| Designation |
PG Scholar |
| Affiliation |
Pt. Khushilal Sharma Govt. (Auto.) Ayurveda College and Institute Bhopal mp. |
| Address |
Room NO 228 Department of agad tantra Pt. Khushilal Sharma Govt. Ayurveda College and Institute Bhopal m.p.Behind Manit Science hills Bhopal m.p.
Room NO 228 Department of agad tantra Pt. Khushilal Sharma Govt. Ayurveda College and Institute Bhopal m.p.Behind Manit Science hills Bhopal m.p.
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
09752602962 |
| Fax |
|
| Email |
jagratiahirwar17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepika Thakur |
| Designation |
Lecturer |
| Affiliation |
Pt. Khushilal Sharma Govt. (Auto) Ayurveda College and Institute Bhopal mp. |
| Address |
Room NO 227 Department of agad tantra Pt. Khushilal Sharma Govt. Ayurveda College and Institute Bhopal m.p.Behind Manit Science hills Bhopal m.p.
Room NO 227 Department of agad tantra Pt. Khushilal Sharma Govt. Ayurveda College and Institute Bhopal m.p.Behind Manit Science hills Bhopal m.p.
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8143449578 |
| Fax |
|
| Email |
deepika.smiling@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jagrati Ahirwar |
| Designation |
P.G scholar |
| Affiliation |
Pt. Khushilal Sharma Govt. (Auto) Ayurveda College and Institute Bhopal mp. |
| Address |
Room NO 228 Department of agad tantra Pt. Khushilal Sharma Govt. Ayurveda College and Institute Bhopal m.p.Behind Manit Science hills Bhopal m.p.
Room NO 228 Department of agad tantra Pt. Khushilal Sharma Govt. Ayurveda College and Institute Bhopal m.p.Behind Manit Science hills Bhopal m.p.
Bhopal
MADHYA PRADESH
462003
India |
| Phone |
8143449578 |
| Fax |
|
| Email |
jagratiahirwar17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. Khushilal Sharma Govt. Ayurveda College and Institute Bhopal m.p. |
|
|
Primary Sponsor
|
| Name |
Pandit Khushilal Sharma govt autonomous ayurveda college and institute Bhopal mp |
| Address |
Nehru Nagar kolar bypass road science hills behind MANIT Bhopal |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Jagrati Ahirwar |
Pt. Khushilal Sharma Govt. (Auto) Ayurveda College and Institute Bhopal mp. |
Pandit Khushilal Sharma Govt (Auto) Ayurveda College and Institute Bhopal Behind MANIT Science hills bhopal
Bhopal
MADHYA PRADESH |
09752602962
jagratiahirwar17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pt. Khushilal sharma government ayurveda institute, Bhopal (MP) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M206||Acquired deformities of toe(s), unspecified. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Langali gutika, Reference: Bhavprakash samhita, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dhaturadya taila, Reference: Bhavprakash samhita, Route: Topical, Dosage Form: Taila, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: - | | 3 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: placebo, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with classical sign & symptoms of Vatarakta and Uric acid level more than 7mg/dl for male and 6mg/dl for female.
2.Patients between the ages of 20 years to 60 years.
|
|
| ExclusionCriteria |
| Details |
1. Age below 20 years and above 60 years.
2. Patient associated with any other systemic disease e.g., Diabetes, Hypertension, Severe cardiac disease etc.
3. Pregnancy and lactating mother.
4. Patient without written consent form.
5. Female patient with PCOD and heavy Bleeding in Menses.
6. Patient presenting with tophi, cellulitis, renal and liver disorder, bone deformities, rheumatoid arthritis and Osteoarthritis.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| It is expected that at the end of study we would be able to demonstrate the efficacy of Langali Gutika and Dhaturadya Taila in the management of Vatarakta |
NIL |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| At the end of study we would be able to demonstrate the efficacy of Langali Gutika And Dhaturadya Taila in the management of Vatarakta |
Nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
05/03/2025 |
| 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 Yet Recruiting |
| 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
|
Langali and Dhatura are considered in the upavishas,which cure many illnesses but may prove fatal on misuse. Langali is known for its high Colchicine content to be used in gout. Dhatura is well known for its insecticidal, herbicidal, antifungal, antibacterial, anticancer, anti inflammatory and anti-rheumatoid activity. Nowadays human beings are vulnerable to many disorders due to their altered lifestyle and food habits. Occurrence of Vatarakta is one of the outcomes of these modifications. In Ayurveda texts vata is the most significent among Tridoshas, and life of living beings absolutely depend on rakta dhatu. Vatarakta is a condition in which aggravated vata (due to mithya ahar-vihar) is obstructed in its path by aggravated rakta and obstructed vata once again vitiates rakta producing the disease which is characterized mainly by features like daha(Burning), toda(Pricking pain), Sandhi shool(Pain) and Sandhi sotha(Swelling) of affected joint along with discolouration of the surrounding skin. |