| CTRI Number |
CTRI/2025/12/098719 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
09/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical effect of Langladyam Loham and Kaishor Guggul in Vatarakta. |
|
Scientific Title of Study
|
A Randomized controlled clinical trial to compare the efficacy of Langladyam Loham with Kaishor Guggul 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 Pritesh Jaiswal |
| Designation |
Associate Proffesor |
| Affiliation |
Shri Ayurved Mahavidyalaya |
| Address |
Shri Ayurved Mahavidyalaya, Kayachikitsa Department OPD no 2, Ground floor, Budhwar Bazar Road, Krida Chowk, Raghuji Nagar, Nagpur
Nagpur MAHARASHTRA 440024 India |
| Phone |
7757099257 |
| Fax |
|
| Email |
dr.priteshjaiswal@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Medha Mahesh Joshi |
| Designation |
Proffesor |
| Affiliation |
PDEAs College of Ayurved And Research Center Pune |
| Address |
PDEAs College of Ayurved And Research Center, Kayachikitsa Department, OPD Ground Floor, And IPD of Kayachiktsa Department First Floor, Sector No 27, Pradhikaran , Nigdi Pune
Pune MAHARASHTRA 411044 India |
| Phone |
9881465798 |
| Fax |
|
| Email |
medhamaheshjoshi@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Pritesh Jaiswal |
| Designation |
Associate Proffesor |
| Affiliation |
Shri Ayurved Mahavidyalaya Nagpur |
| Address |
Shri Ayurved Mahavidyalaya, Kayachikitsa Department OPD no 2, Ground floor, Budhwar Bazar Road, Krida Chowk, Raghuji Nagar, Nagpur
Nagpur MAHARASHTRA 440024 India |
| Phone |
7757099257 |
| Fax |
|
| Email |
dr.priteshjaiswal@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved And Research Centre Nigdi Pune 411044 |
| Shri Ayurved Mahavidyalaya, Nagpur 440024 |
|
|
Primary Sponsor
|
| Name |
Dr. Pritesh Jaiswal |
| Address |
Shri Ayurved Mahavidyalaya Krida Chowk, Nagpur 440024 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pritesh Jaiswal |
Pakwasa Samanvay Rughnalaya |
Kayachikitsa OPD No 2, Ground Floor and IPD First Floor, Krida Chowk, Nagpur 440024 Nagpur MAHARASHTRA |
7757099257
dr.priteshjaiswal@gmail.com |
| Dr Pritesh Jaiswal |
PDEAs College of Ayurved & Research Institute and Affilated Hospital (ARSMH) |
Department of Kayachikitsa OPD No 117, Sector No 25, Pradhikaran, Nigdi, Pune Maharashtra 411044 Pune MAHARASHTRA |
7757099257
dr.priteshjaiswal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M103||Gout due to renal impairment. Ayurveda Condition: VATARAKTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kaishor Guggul, Reference: Bhaishjya Ratnawali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Koshna Jal), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: LangaladyLoham, Reference: Rassendrasar Sangraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Madhu 5 gm), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient having signs and symptoms or Vatarakta such as Sandhi Shula (pain), Sandhi Shotha (Swelling), Sparshaashatva (Tenderness), Twak Vaivarnya (Discolouration of skin.
2. Patient from age group between 20-65 years old, irrespective of their sex, religion geographical area.
3. Patient having uric acid level greater than 7 mg/dl in male ^ 6 mg/dl in female. |
|
| ExclusionCriteria |
| Details |
1. Patient having severe disorder like renal disorder-acute and chronic renal failure, poly nephritic syndrome, Liver disorder, Liver cirrhosis, Hepatitis, Neurological Disorder.
2. Patient having sexual transmitted disease and immunosuppressant disorder.
3. Lactating Mothers, Pregnant Women.
4. Patient having Rheumatoid arthritis, Psoriatic arthritis , any joint replacement surgery, and any chronic illness.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of Langladyam Loham with Kaishor Guggul in the management of Vatarakta,
To evaluate the efficacy of Langladyam Loham on biochemical markers and to assesst the side effect if any. |
Duration of the study- 36 months.
Duration of treatment: 30 days follow up 7th day, 14th day,21st day and 31st day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study adverse effect if any.
To assess the efficacy of Langladyam Loham And Kaishor Guggul on biochemical markers |
Duration of the study- 36 months.
Duration of treatment: 30 days follow up 7th day, 14th day,21st day and 31st day
|
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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)
|
07/12/2026 |
| 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="3" 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
|
Gout is a medical condition usually characterized by recurrent attack of acute inflammatory arthritis – a red, tender, hot, swollen joint. The metatarsal – Phalangeal joint at the base of big toe is most commonly affected. Increase production of uric acid as cause of gout is seen in only 10 to 15 % of subject and 80-90% uric acid excretion is impared. The deposition of Mono-sodium Urate crystal in joints causes Gouty Arthritis, in soft tissues causing tophi and tenosynovitis. The general prevalence of Gout is 1-4% of the general population. It occurs in men 2-6 folds more than women. World wild incidence of Gout increases gradually due to poor dietary habits such as fast food, lack of exercises , increase incidence of abesity and metabolic syndrome. In Ayurveda the nearest co-relation of Gout can be made with Vatarakta. It is a disease of MadhyamRoga Marga as it affects mainly Sandhis. (Parvasandhis). Vatarakta is caused by Adhyashana , Virudhaashana, Divasawpna, etc. Due to these Nidanas vata and rakta gets vitiated. Aggravated vata is blocked by vitiated Raktas circulate very fast all over the body due to the Sukshma and Drava Guna of Vata and Rakta respectively and undergo DoshaDushyaSammurchana in Sandhi Sthana specifically in Kar, Pada, Angula sandhi. The classical symtoms are Vatarakta kandu, Shawaythu , Bheda, Toda, Shula, Kathinya, Sparshasahavta. Ayurveda can provide a very good holistic treatment option. Today there is need to fine the drug which gives long term relief without any adverse effect. LangdadyLoham is one of the Kalpa mention for Vatarakta Chikitsa , It has anti inflammatory properties which helps to reduce the pain. Langli act as Shoolprashaman , KaphaVatashamak. This drugs shows antagonistic action on Prakupit Vata doshas & Rakta dhatu involved on Vatarakta. This Kalpa is proposed to shows an efficient action on pathology of this disease. The ingredients used in the LangladyamLoham are easily available and cost effective. Comparatively by using the Ayurvedic formulation and dietary regulation the sign and symptoms of Vatarakta are decreases without any side effect. In previous study Kaishor Guggul was found be to be Significant in the management of of Vatarakta. The present study is carried out to study the efficacy of an ayurvedic herbal compound LangladyLoham on biochemical markers- uric acid level , CBC, CRP, ESR. |