| CTRI Number |
CTRI/2023/09/057542 [Registered on: 13/09/2023] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| 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 evaluate effect of munditika churna and Haritaki churna in the management of Vatarakta (gout) |
|
Scientific Title of Study
|
Randomised controlled clinical trial of efficacy of Munditika churna and Haritaki churna in the management of Vatarakta (gout) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pathan Md Junaid Naim Khan |
| Designation |
Associate professor |
| Affiliation |
Pravara medical trusts ayurved college, shevgaon |
| Address |
OPD no. 07, department of Kayachikitsa,SSTs ayurved college, Sangamner, Dist - Ahmadnagar
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
7709483864 |
| Fax |
|
| Email |
junaidklm86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shinde Bhagwat T |
| Designation |
Principal |
| Affiliation |
Pravara medical trusts ayurved college, Shevgaon |
| Address |
Pricipal office, Pravara medical trusts ayurved college, Shevgaon
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
9922709070 |
| Fax |
|
| Email |
sbhagwat.2007@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pathan Md Junaid Naim Khan |
| Designation |
Associate professor |
| Affiliation |
Pravara medical trusts ayurved college, Shevgaon |
| Address |
OPD no. 07, department of Kayachikitsa,SSTs ayurved college, Sangamner, Dist - Ahmadnagar
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
7709483864 |
| Fax |
|
| Email |
junaidklm86@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sangam Sevabhavi trusts ayurved college, Sangamner, Dist - Ahmadnagar |
|
|
Primary Sponsor
|
| Name |
Pathan Md Junaid Naim Khan |
| Address |
OPD no. 07, department of Kayachikitsa,SSTs ayurved college, Sangamner, Dist - Ahmadnagar422605 |
| 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 |
| Pathan Md Junaid Naim Khan |
Sanjivan hospital & research centre |
OPD no. 07, department of Kayachikitsa, Nasik-Pune highway, Sangamner, dist- ahmednagar MH 422605
Ahmadnagar
MAHARASHTRA |
7709483864
junaidklm86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sangam sevabhavi trusts ayurved college, sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M1A9||Chronic gout, unspecified. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haritaki, Reference: Bhaishajya ratnavali 27/08, Route: Oral, Dosage Form: Churna/ Powder, Dose: 02(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Gula- 02gms), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Munditika, Reference: Bhaishajya ratnavali 27/36, Route: Oral, Dosage Form: Churna/ Powder, Dose: 05(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Madhu - 05ml, Go-ghrita - 10ml), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants having classical sign & symptoms of Vatarakta like - 1. Shotha (Swelling)
2. Kathinya (Stiffness & Hardness)
3. Vedanadhikya (Severe pain)
4. Daha (Burning sensation)
5. Toda (Pricking pain)
6. Shyavata & tamrata (Blackish or Coppery)
7. Sphurana (Twitching sensation)
8. Participants having age group between 18 years to 60 years
9. Participants having Serum Uric acid level > 7 mg/dl in Males & >6 mg/dl in Females
10. Participants will be selected irrespective Gender, Religion, Socio-Economic status |
|
| ExclusionCriteria |
| Details |
1. Participants having complications like Paka, Khanja, Pangulya and Sandhi vakrata will be excluded.
2. Alcohol and drug abusers, Pregnant and lactating women
3. Symptomatic participants with clinical evidence of Kidney failure
4. k/c/o Malignancy, poorly controlled DM, HTN
5. Participants having other acute or complicated systemic disease which require long term drug treatment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in vatarakta sign & symptoms |
15th, 30th, 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| decrease in Hyperuricemia (Sr. Uric acid) level |
45th day |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
25/09/2023 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Vatrakta is one of the Vatavyadhis, a disease where both Vata and Rakta are afflicted by distinct
etiological factors. There are 02 types of Vatarakta i.e., Uttana Vatarakta produces symptoms
like itching, burning sensation, pain, brown-blackish discolouration of skin. While, Gambhira
Vatarakta produces symptoms like swelling, hardness, tenderness, burning sensation, pain.
Sometimes numbness is also present. Vatarakta can be corelated with Gout. Gout is the most common inflammatory arthritis in men and in older women. Gout is the most
common form of inflammatory arthritis.
As the level of uric acid [in men (≤ 7 mg/dl) and women (≤ 6 mg/dl)] crosses its saturation
thresholds in physiological fluids urate crystals precipitation starts in the joints leading to gout. In Ayurveda Vatarakta has been described in detail with different useful treatment modalities.
One of such treatment for Vatarakta is classicaly recommended in Bhaishajya ratnavali is
Munditika churna & Haritaki churna. so, this RCT is planned to evaluate efficacy of both these churna (Munditika & Haritaki churna). The main outcome of this trial is to evaluate improvement in symptoms viz. 1. Shotha (Swelling)
2. Kathinya (Stiffness & Hardness)
3. Vedanadhikya (Severe pain)
4. Daha (Burning sensation)
5. Toda (Pricking pain)
6. Shyavata & tamrata (Blackish or Coppery joint discolouration)
7. Sphurana (Twitching sensation) and changes in changes in sr. Uric acid levels. |