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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  
Name  Address 
Nil  Nil 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M103||Gout due to renal impairment. Ayurveda Condition: VATARAKTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(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: -
2Intervention ArmDrugClassical(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.

 
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