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CTRI Number  CTRI/2022/09/045953 [Registered on: 27/09/2022] Trial Registered Prospectively
Last Modified On: 05/09/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Other 
Public Title of Study   TREATMENT OF GRAHANI THROUGH AYURVEDA 
Scientific Title of Study   A CLINICAL STUDY ON THE ROLE OF AGNI IN RELATION TO GRAHANI AND ITS MANAGEMENT BY NAGARADHYA CHURNA  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr NANDINI SHARMA  
Designation  P G SCHOLAR  
Affiliation  UNIVERSITY POST GRADUATE INSTITUTE OF AYURVED STUDIES AND RESEACRH JODHPUR 
Address  P G DEPARTMENT OF KAYACHIKITSA, UNIVERSITY POST GRADUATE INSTITUTE OF AYURVED STUDIES AND RESEARCH, Dr SARVEPALLI RADHAKRISHNAN RAJASTHAN AYURVED UNIVERSITY, JODHPUR, RAJASTHAN, 342037

Jodhpur
RAJASTHAN
342037
India 
Phone  9165723463  
Fax    
Email  nandinisharmans822@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr PRAMOD KUMAR MISHRA 
Designation  PROFESSOR AND HOD 
Affiliation  UNIVERSITY POST GRADUATE INSTITUTE OF AYURVED STUDIES AND RESEARCH JODHPUR  
Address  P G DEPARTMENT OF KAYACHIKITSA, UNIVERSITY POST GRADUATE INSTITUTE OF AYURVED STUDIES AND RESEARCH, Dr SARVEPALLI RADHAKRISHNAN RAJASTHAN AYURVED UNIVERSITY, JODHPUR, RAJASTHAN, 342037

Jodhpur
RAJASTHAN
342037
India 
Phone  9001009793  
Fax    
Email  drpramodmishra4@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr NANDINI SHARMA  
Designation  P G SCHOLAR  
Affiliation  UNIVERSITY POST GRADUATE INSTITUTE OF AYURVED STUDIES AND RESEARCH JODHPUR  
Address  P G DEPARTMENT OF KAYACHIKITSA, UNIVERSITY POST GRADUATE INSTITUTE OF AYURVED STUDIES AND RESEARCH, Dr SARVEPALLI RADHAKRISHNAN RAJASTHAN AYURVED UNIVERSITY, JODHPUR, RAJASTHAN, 342037

Jodhpur
RAJASTHAN
342037
India 
Phone  9165723463  
Fax    
Email  nandinisharmans822@gmail.com  
 
Source of Monetary or Material Support  
UNIVERSITY POST GRADUATE INSTITUTE OF AYURVED STUDIES AND RESEARCH,JODHPUR 
 
Primary Sponsor  
Name  UNIVERSITY POST GRADUATE INSTITUTE OF AYURVED STUDIES AND RESEARCH JODHPUR RAJASTHAN  
Address  UNIVERSITY POST GRADUATE INSTITUTE OF AYURVED STUDIES AND RESEARCH, Dr SARVEPALLI RADHAKRISHNAN RAJASTHAN AYURVED UNIVERSITY, JODHPUR, RAJASTHAN, 342037 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Dr NANDINI SHARMA   P G DEPARTMENT OF KAYACHIKITSA, UNIVERSITY POST GRADUATE INSTITUTE OF AYURVED STUDIES AND RESEARCH, Dr SARVEPALLI RADHAKRISHNAN RAJASTHAN AYURVED UNIVERSITY, JODHPUR, RAJASTHAN, 342037 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr NANDINI SHARMA  UNIVERSITY POST GRADUATE INSTITUTE OF AYURVED STUDIES AND RESEARCH JODHPUR RAJASTHAN   P G DEPARTMENT OF KAYACHIKITSA (OPD NO 4), UNIVERSITY POST GRADUATE INSTITUTE OF AYURVED STUDIES AND RESEARCH, Dr SARVEPALLI RADHAKRISHNAN RAJASTHAN AYURVED UNIVERSITY, JODHPUR, RAJASTHAN, 342037
Jodhpur
RAJASTHAN 		 9165723463

nandinisharmans822@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE OF ETHICS COMMITTEE, UNIVERSITY POST GRADUATE INSTITUTE OF AYURVED STUDIES AND RESEARCH JODHPUR RAJASTHAN   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K639||Disease of intestine, unspecified. Ayurveda Condition: GRAHANI ROGA ,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: NAGARADHYA CHURNA , Reference: CHARAK CHIKITSA 15/56, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: HONEY AND RICE WATER), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients having following symptom of Grahani (Amavastha):
1. Muhur Baddha mala pravritti / vibaddha (constipation)
2. Muhur drava mala pravritti / dravam (diarrhoea)
3. Ama Mala Pravritti (sticky stool)
4. Aruchi (anorexia)
5. Udara Shoola (abdominal pain)
6. Atopa (bloating)
7. Amla Udgar (burning sensation)
8. Udar Gaurava (heaviness in abdomen)
9. Parva ruka (bodyache)
10. Jwara (fever) 
 
ExclusionCriteria 
Details  a) Age below 18 and above 60 years.
b) Patients suffering from Intestinal tuberculosis, Gastric & Peptic ulcer.
c) Patients with complicated and chronic disorders like Nephrotic syndrome, Jaundice,
Hepatitis, Chronic infections and other serious diseases.
d) Pregnant women and lactating mothers.
e) Patients suffering from Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus.
f) Systemic illness like Tuberculosis, Carcinoma and Endocrine disorders.
g) Patient having the major Renal or Liver disorders.  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
TO EVALUATE THE CLINICAL EFFICACY OF NAGARADHYA CHURNA IN THE MANAGEMENT OF GRAHANI ROGA   45 DAYS  
 
Secondary Outcome  
Outcome  TimePoints 
TO EVALUATE THE CLINICAL EFFICACY OF NAGARADHYA CHURNA IN THE MANAGEMENT OF GRAHANI ROGA   45 DAYS  
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/10/2022 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NONE YET 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   In the present era, Grahani Roga is a common GI Tract disorder affecting daily life because of its direct link with improper food habits and stressful lifestyle.
Grahani is the main functional part of Mahasrota in between Amashaya & Pakwashaya, also known as the 6 th Kala i.e. Pittadhara Kala where Jatharagni resides and its main function is to hold the Ahara up to the end of Awasthapaka & after completion passes it into Pakwashaya. Any individual, who is suffering from symptoms like alternate passing of hard & loose bowel habits, abdominal pain, passing of foul-smelling stool, mucus in fecal matter can be diagnosed as Grahani Roga.
So, an attempt has been made in this context to understand the concept of Grahani Roga on the basis of Ama, Agni and Pachana Kriya.
Grahani is a disease which affects large population globally especially in developing country and associated with improper food habits along with stressful lifestyle. In the present scientific era, people are fed up with the side effects of the most effective and fast acting modern drugs, which are lowering the human immunity at the same time when they are suppressing disease.
Therefore, Ayurvedic herbal formulation ‘Nagradhya Churna’ is beneficial to help the patients suffering from Grahani Roga and they can positively influence health and quality of life, that’s why present study is being launched. 
Trial drug is found with following properties: deepana, pachana, sangrahi, vedna sthapaka, balya and etc.
in a view of above study to know the aetiopathogenesis of grahani roga , to evaluate the efficacy, safety, sustainability & adverse drug reactions of the trial drug. 
 
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