| CTRI Number |
CTRI/2026/03/105326 [Registered on: 03/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
“A clinical study to assess the effectiveness of Ayurvedic medicines, with and without leech therapy, in the management of gout.” |
|
Scientific Title of Study
|
A Comparative Clinical Study to Evaluate the efficacy of Punarnava amrita Guggulu and Rasnadi Kwath in Cases of Vatarakta with and without Raktmokshan by Jalauka with special reference to Gout |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepraj Singh |
| Designation |
M.D. SCHOLAR |
| Affiliation |
State Ayurvedic College and Hospital Lucknow |
| Address |
P.G Department of Kaya Chikitsa , State Ayurvedic College and
Hospital, Lucknow
Lucknow
UTTAR PRADESH
226004
India
P.G Department of Kaya Chikitsa , State Ayurvedic College and
Hospital, Lucknow
Lucknow
UTTAR PRADESH
226004
India
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
7007249941 |
| Fax |
0 |
| Email |
deeprajsingh65@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharad Johri |
| Designation |
Reader |
| Affiliation |
State Ayurvedic College and Hospital Lucknow |
| Address |
P.G Department of Kaya Chikitsa , State Ayurvedic College and
Hospital, Lucknow
Lucknow
UTTAR PRADESH
226004
India
P.G Department of Kaya Chikitsa , State Ayurvedic College and
Hospital, Lucknow
Lucknow
UTTAR PRADESH
226004
India
Lucknow
UTTAR PRADESH
226004
India |
| Phone |
9140686337 |
| Fax |
0 |
| Email |
sharadjohri47@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharad Johri |
| Designation |
Reader |
| Affiliation |
State Ayurvedic College and Hospital Lucknow |
| Address |
P.G Department of Kaya Chikitsa , State Ayurvedic College and
Hospital, Lucknow
Lucknow
UTTAR PRADESH
226004
India
P.G Department of Kaya Chikitsa , State Ayurvedic College and
Hospital, Lucknow
Lucknow
UTTAR PRADESH
226004
India
UTTAR PRADESH
226004
India |
| Phone |
9140686337 |
| Fax |
0 |
| Email |
sharadjohri47@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Ayurvedic College and hospital, Tulsidas Marg, Turiyaganj, Lucknow, Uttar Pradesh
226004, India |
|
|
Primary Sponsor
|
| Name |
State Ayurvedic College and Hospital Lucknow |
| Address |
State Ayurvedic College and hospital, Tulsidas Marg, Turiyaganj,
Lucknow, Uttar Pradesh 226004, India
|
| Type of Sponsor |
Government 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 Deepraj Singh |
State Ayurvedic college and hospital Lucknow |
OPD no.6, PG
Department of
Kaya chikitsa, State
Ayurvedic College and
hospital, Tulsidas Marg,
Turiyaganj, Lucknow,
Uttar Pradesh 226004,
India
Lucknow
UTTAR PRADESH
Lucknow
UTTAR PRADESH |
7007249941
0
deeprajsingh65@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of Institutional Ethics Committee, State Ayurvedic College and Hospital, Lucknow |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M959||Acquired deformity of musculoskeletal system, unspecified. Ayurveda Condition: VATARAKTAM, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Punarnava Amrita guggulu, Reference: chakradatta, Route: Oral, Dosage Form: Guggulu , Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -rasnadi kwath), Additional Information: - | | 2 | Comparator Arm | Procedure | - | jalaukAvacaraNam, जलौकावचरणम् | (Procedure Reference: Sushrut samhita sutra sthan thirteen , Procedure details: Purva Karma
The leech is purified in turmeric water. The affected area is cleaned & dried properly for easy attachment.
Pradhana Karma
An active leech is placed on the diseased area. If needed, a small prick is given to help attachment. It sucks about five to fifteen ml blood and detaches on its own. Turmeric or rock salt can be used to remove it.
Paschat Karma
Mild bleeding may occur due to hirudin. Shatadhauta ghrita and Yashtimadhu powder are applied to the wound. The leech is cleaned and stored)
(1) Medicine Name: Punarnava Amrita guggulu, Reference: chakradatta, Route: Oral, Dosage Form: Guggulu, Dose: 1000(mg), Frequency: bd, Duration: 30 Days(2) Medicine Name: Rasnadi kwath, Reference: vranda madhava, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 40(ml), Frequency: bd, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: Individuals between 21 and 60 years.
2. Gender: Both males and females will be included.
3. Socioeconomic Status: Participants from all socioeconomic backgrounds are eligible.
4. In case of Jalauka Avcharana BT, CT, INR, within normal limits and patients having
HB percent grater than 10 gm percent.
5. Clinical Parameters: Patients diagnosed with Vatarakt who have serum uric acid
levels exceeding 7 mg per dl in males and 6 mg per dl in females. Additionally, they must fulfill
all three essential diagnostic criteria along with at least one non-essential criterion. |
|
| ExclusionCriteria |
| Details |
1. Individuals younger than 21 years or older than 60 years.
2. In case of Jalauka Avcharana patient having HB percentage less than 10gm percentage, any coagulative disorders,
uncontrolled hypertension and Diabetes mellitus.
3. Cases of gouty arthritis complicated by systemic conditions such as uncontrolled diabetes,
thyroid dysfunctions, or psoriatic arthritis.
4. Patients with advanced Vatarakta presenting with complications like hiccups, fainting, delirium, erysipelas, muscular abscess, or finger deformities.
5. Gout cases accompanied by chronic joint deformity, significant loss of joint function, or
presence of draining tophi.
6. Women who are pregnant or Lactating.,
7. Patients diagnosed with rheumatoid arthritis, osteoarthritis, systemic lupus erythematosus
,tuberculosis, or those suffering from renal or liver disorders.
8. Patients having serum uric acid grater than 10.3 mg per dl in females and grater than 11.6 mg per dl in males. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To establish the comparative efficacy of Punarnava amrita guggulu & Rasnadi kwath in case of
Vatrakta with and without raktmokshan (by Jaluka).
2.To evaluate the clinical efficacy of Punarnava Amrita Guggulu and Rasnadi Kwath in the
management of Vatarakta (Gout), with and without Raktamokshana (Jaluka). |
Duration of clinical trial - 30 days.
Follow up during treatment – 7, 15, 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the role of Raktamokshana (Jaluka) as an adjunct to oral therapy in reducing
symptoms such as Shotha (swelling), Shula (pain), and Daha (burning) in Vatarakta.
2. To compare the therapeutic outcomes between the two groups:
o Group A: Treated with Punarnava Amrita Guggulu and Rasnadi Kwath alone.
o Group B: Treated with Punarnava Amrita Guggulu, Rasnadi Kwath, and
Raktamokshana.
3. To analyze improvements in subjective parameters weekly and objective parameter like
serum uric acid level at 0, 15th and 30th day of trial.
4. To assess the side effect of drugs and Raktmoksan (by jaluka) if any. |
1.Duration of clinical trial - 30 days.
2.Follow up during treatment – 7, 15, 30 days
3.Follow up without drug – 7 days.
(Jaluka Avshechan – Once in a week for 1 month at morning i.e. total 5 times during complete
trial at the day 0, 7, 14, 21, 28 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 |
|
Date of First Enrollment (India)
|
03/03/2026 |
| 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="5"
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
|
This clinical trial is a comparative study conducted to evaluate the efficacy of Punarnava Amrita Guggulu and Rasnadi Kwath with and without Raktamokshana by Jaluka in the management of Vatarakta with special reference to Gout. A minimum of 60 patients diagnosed with Vatarakta/Gout will be randomly divided into two groups, where Group A will receive Punarnava Amrita Guggulu (1 g twice daily) along with Rasnadi Kwath (40 ml twice daily), and Group B will receive the same oral medication along with weekly Jaluka Avacharana for one month. The total duration of treatment is 30 days with scheduled follow-ups. Therapeutic efficacy will be assessed based on improvement in subjective parameters such as pain, swelling, tenderness, stiffness, and burning sensation, along with objective evaluation of serum uric acid levels. The study aims to assess the additional role of Raktamokshana as an adjunct to oral Ayurvedic therapy in providing effective, safe, and holistic management of Vatarakta (Gout). |