| CTRI Number |
CTRI/2026/02/102970 [Registered on: 04/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| 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
|
Effect of laghu manjishthadi kwatha in the management of vatarakta |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate the efficacy of laghu manjisthadi kwatha in the management of vata rakta (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 |
Dr Komal Manoj Rathi |
| Designation |
Pg Scholar |
| Affiliation |
C.S.M.S.S Ayurved mahavidyalaya and rugnalaya |
| Address |
OPD no 13 Kayachikitsa department C.S.M.S.S ayurved mahavidyalaya and rugnalaya, kanchanwadi, aurangabad 431011
Aurangabad Maharashtra
431011
India
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9096111391 |
| Fax |
|
| Email |
komalrathi2017@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naresh Ramrao Nimbalkar |
| Designation |
Professor |
| Affiliation |
C.S.M.S.S Ayurved mahavidyalaya and rugnalaya |
| Address |
OPD no 13 Kayachikitsa department C.S.M.S.S Ayurved mahavidyalaya and rugnalaya, Kanchanwadi, Aurangabad 431011
Aurangabad Maharashtra
431011
India
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9422711098 |
| Fax |
|
| Email |
ayushakti009@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komal Manoj Rathi |
| Designation |
Pg Scholar |
| Affiliation |
C.S.M.S.S Ayurved mahavidyalaya and rugnalaya |
| Address |
OPD no 13 Kayachikitsa department C.S.M.S.S Ayurved mahavidyalaya and rugnalaya, Kanchanwadi, Aurangabad 431011
Aurangabad Maharashtra
431011
India
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9096111391 |
| Fax |
|
| Email |
komalrathi2017@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD no 13 KAYACHIKITSA department C.S.M.S.S Ayurved mahavidyalaya and rugnalaya, Kanchanwadi, Aurangabad 431011
Aurangabad MAHARASHTRA
431011
India
|
|
|
Primary Sponsor
|
| Name |
Dr Komal Manoj Rathi |
| Address |
OPD no 13 KAYACHIKITSA department C.S.M.S.S Ayurved mahavidyalaya and rugnalaya, Kanchanwadi, Aurangabad 431011
Aurangabad MAHARASHTRA
431011
India
|
| Type of Sponsor |
Private medical college |
|
|
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 Komal Manoj Rathi |
C.S.M.S.S Ayurved mahavidyalaya and rugnalaya |
OPD no 13 Kayachikitsa department C.S.M.S.S Ayurved mahavidyalaya and rugnalaya, Kanchanwadi, Aurangabad 431011
Aurangabad Maharashtra
431011
India
Aurangabad
MAHARASHTRA |
9096111391
komalrathi2017@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC C.S.M.S.S Ayurved mahavidyalaya and rugnalaya, Kanchanwadi, Aurangabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M109||Gout, unspecified. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: LAGHU MANJISTHADI KWATH, Reference: Sharangdhar Samhita Madhyam Khand Adhaya 2 shloka 140, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Koshna Jala), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: GOKSHURADI GUGGULU, Reference: Sharangdhar Samhita Madhyam khand Adhyay 7 shloka no 84-87, Route: Oral, Dosage Form: Guggulu , Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Koshna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having sign and symptoms of purva rupa(early symptoms) and
rupa (symptoms) of Vatarakta.
2. Symptoms of Vatarakta
a. Sandhishool (Pain)
b. Sandhidaha (Burning sensation)
c. Sandhishoth (Swelling)
d. Sparshasahtva (Tenderness)
e. Sandhistabdhata (Stiffness)
3. Patients showing sign and symptoms of Vatarakta less than 1 year.
4. Patients having uric acid level
more than 7mg/dl in male.
more than 6mg/dl in female. |
|
| ExclusionCriteria |
| Details |
1. Patients below 20 and above 70 years of age.
2. Long standing chronic cases of Vatarakta with Updrava of Vatarakta.
3. Patients having Inflammatory joint disorder such as
osteoarthritis,tubercular arthritis .
4. Patients with auto immune joint disorder except RA.
5. Patients suffering from carcinoma.
6. Patients having HIV and other immunocomprisive disease.
7. Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Sandhishool (Pain)
2.Sandhidaha (Burning sensation)
3.Sandhishoth (Swelling)
will be reduced |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Sparshashatva (Tenderness)
2.Sandhistabdhata (stiffness)
will be reduced |
21 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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
16/02/2026 |
| 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="6"
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
|
Vatarakta is described under vatavyadhi nidan adhyaya by achrya shushrut
and acharya vagbhata and acharya charaka has given separate chapter for
this disease.It is madhyam marg gat vyadhi because it mainly affects
sandhis. Vatarakta is named on the basis of Vata dosha and Rakta dhatu which have
their own independent derivations and are the main samprapti ghataka
involved in the vatarakta. It is considered that the life of all living beings
depends on Rakta. By excessive intake of hot,sour,irritant,alkaline food
items,exposure to too much heat Rakta dhatu gets vitiated and if the same
individuals with vitiated Rakta dhatu starts taking Vata prakopak ahara and
vihara,it will cause vitiation of vata dosha. It can be correlated with Gout due to similaritis in their symptoms.These
days,due to rapid modernization ,consumption of half fried food or baked
food causes impairement in digestion and metabolism making human being
prone to many life threating ailments like stroke or functional impairement
like in joint disorders.
Among all these ailments vatarakta is a common presentation with
symptoms like severe pain, inflammation, burning sensation and
tenderness in the aggected joints.Gout is the true crystal deposition disease
and it is a pathological reaction of the joint or particular tissue to the
presence of monosodium urate monohydrate crystals. |