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CTRI Number  CTRI/2024/07/071310 [Registered on: 25/07/2024] Trial Registered Prospectively
Last Modified On: 24/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Panchkarma Procedure (Piccha Basti) And Ayurvedic Medicine (Lajjalu Churna) In The Management of Grahani Dosh W.S.R to IBD.  
Scientific Title of Study   A Comparative Study On The Effect Of Oral Administration Of Lajjalu Churna With And Without Kalpit Pichha Basti In The Management Of Grahani Dosh W.S.R IBD 
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 Archana Sharma 
Designation  PG Schloar  
Affiliation  Dayanand Ayurvedic College 
Address  Department Of Panchakarma, Dayanand Ayurvedic College, Mahatma Hansraj Marg, Gurdev Nagar, Jalandhar (Punjab), Pin Code- 144008, India

Jalandhar
PUNJAB
144008
India 
Phone  8360192660  
Fax    
Email  sharmaarchu1201@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gayathri M Prakash  
Designation  Assistant Professor  
Affiliation  Dayanand Ayurvedic College 
Address  Department Of Panchakarma, Dayanand Ayurvedic College, Mahatma Hansraj Marg, Gurdev Nagar, Jalandhar (Punjab), Pin Code- 144008, India

Jalandhar
PUNJAB
144008
India 
Phone  9915561236  
Fax    
Email  gayathriprakash1990.m@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Archana Sharma 
Designation  PG Scholar  
Affiliation  Dayanand Ayurvedic College 
Address  Department Of Panchakarma, Dayanand Ayurvedic College, Mahatma Hansraj Marg, Gurdev Nagar, Jalandhar (Punjab), Pin Code- 144008, India

Jalandhar
PUNJAB
144008
India 
Phone  8360192660  
Fax    
Email  sharmaarchu1201@gmail.com  
 
Source of Monetary or Material Support  
Dayanand Ayurvedic College, Mahatma Hansraj Marg, Jalandhar (Pb), Pin Code- 144008, India 
 
Primary Sponsor  
Name  Dayanand Ayurvedic College 
Address  Dayanand Ayurvedic College, Mahatma Hansraj Marg, Jalandhar (Pb), Pin Code- 144008, India  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Archana Sharma  Dayanand Ayurvedic College And Hospital   Department Of Panchakarma, Dayanand Ayurvedic College, Mahatama Hansraj Marg, Jalandhar (Pb),Pin Code-144008, India
Jalandhar
PUNJAB 		 8360192660

sharmaarchu1201@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DAC Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K529||Noninfective gastroenteritis and colitis, unspecified. Ayurveda Condition: GRAHANIDOSHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Lajjalu Churna, Reference: Charak Sahimta Sutra Sthan Ch-4,Sushrut Samhimta Sutra Sthan ch-16, Ashtang Samgraha- Sutra Sthan ch-16, Bhava Prakrakasa Nigantu,pg- 442-443, kaiyadeva nighantu, pg 199-200, Raj Nighantu pg: 179, nighantu adarsh pg: 524-525, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: water), Additional Information: -
2Comparator ArmProcedure-picCA/picCila-bastiH, पिच्छा/पिच्छिल-बस्तिः (Procedure Reference: Charak Samhita- Chikitsa sthan(14/225-228), Ashtang Hridayam-Chikitsa Sthan (8/125-128), Vangsena Samhita-Rog Adhikar(248-250), Chakradatta Chikitsa Sthan (73/34), Sharangdhar Sahimta, Niruhbasti viddhi (6/23-24), Procedure details: (Procedure Reference: Charak Samhita- Chikitsa sthan(14/225-228), Ashtang Hridayam-Chikitsa Sthan (8/125-128), Vangsena Samhita-Rog Adhikar(248-250), Chakradatta Chikitsa Sthan (73/34), Sharangdhar Sahimta, Niruhbasti viddhi (6/23-24), Procedure details: The Kwath Dravya of Kalpit Piccha Basti are as follows –Shalmali Pushp, Vata Shung, Udumbar Shung, Peepal Shung, Laal Chandan, Vidaari Kanda, Vatt Patra, Lisoda. (total-16 gm) The Kalka Dravyas of Kalpit Piccha Basti are as follows-Mochras, Vatsak, Nagarmotha. (total-30 gm) Madhu- 60ml Saindhav Lavan- 4gm Goghrit- 90ml Ksheer Pak-120ml Honey and rock salt will be mixed and churned properly and a homogenous mixture will be made after adding Ghrit after which Kalak Dravya will be added.) 250-300 ml of Piccha basti will be given for 8 days to 30 patients.)
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients who are willing to participate in the
trial.
2. Patients fulfilling the diagnostic criteria.
3. Patients of either sex who are between the age
group 20 to 60 years.
4. Patients who are diagnosed with Grahani on the
basis of with atleast 4 signs and symptoms
Out of eleven mentioned in the texts 45.
5. Patients who are fit for Basti Chikitsa.
 
 
ExclusionCriteria 
Details  1. Patients with the age less than 20 and more than 60.
2. Patients who are suffering from long standing systemic diseases e.g.- hypertension, diabetes, malignancy.
3. Patients with long term Steroid and cytotoxic treatment.
4. Pregnant or lactating women.
5. Patients who are unfit for Basti Chikitsa.
6.Patients who are not willing to continue the treatment.
7.Tubercular IBD will be excluded.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Following index will be assessed for the reduction in their score
For Chron’s Disease- Harvey Bradshaw Index
For Ulcerative Colits Scoring system for the Powell-Tuck Index 		 Assessment
will be done in both the groups.
Day 0 (At the time of enrollment of the patient)
Day 15 (After 7 days of Basti treatment)
Day 30 (After 30 days of oral administration of Lajjalu Churna )
Day 45 (After 45 days of oral administration of Lajjalu Churna )
Day 60 (At follow up) 
 
Secondary Outcome  
Outcome  TimePoints 
Following index will be assessed for the reduction in their score
1.For Chron’s Disease- Harvey Bradshaw Index
2.For Ulcerative Colits Scoring system for the Powell-Tuck Index 		 Assessment
will be done in both the groups.
Day 0 (At the time of enrollment of the patient)
Day 60 (At follow up)  
 
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)   05/08/2024 
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   The total of 60 patients will be selected who are between age group of 20 to 60 years of either sex who are diagnosed with Grahani Rog on the basis of sign and symptoms. Patients will be divided into two groups (Trial Group A and Trial Group B). Group A will be given oral administration of Lajjalu Churna and Kalpit Piccha Basti and Group B will be given  oral administration of  Lajjalu Churna and conduct a clinical study to evaluate the effect of oral administration of Lajjalu Churna in the management of Grahani Rog w.s.r. IBD; to evaluate the effect of oral administration Lajjalu Churna with Kalpit Piccha Basti in the management of Grahani Rog w.s.r. IBD and to compare the effect of oral administration of Lajjalu Churna with and without Kalpit Piccha Basti in the management of Grahani Rog w.s.r. IBD. The total duration of study will be 18 months. 
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