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CTRI Number  CTRI/2023/01/048790 [Registered on: 06/01/2023] Trial Registered Prospectively
Last Modified On: 09/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   To compare the effect of ayurvedic digestive medicines before controlled purgetive procedure in treatment of acne. 
Scientific Title of Study   “A comparative clinical study to assess the role of Pachan given by Paniya Kshar and by Panchakol Churn on the efficacy of Virechana Karma in Yuvanpidika. ” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Proffessor Surendra Vedpathak  
Designation  Professor ,Head Of Department 
Affiliation  National Institute of Ayurveda, Jaipur 
Address  Room number 114 ,department of panchakarma,
new panchakarma building ,madhav vilas palace,joravar singh gate, amer road
Jaipur
RAJASTHAN
302002
India 
Phone  7030309088  
Fax    
Email  drsurendravedpathak50@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Proffessor Surendra Vedpathak  
Designation  Professor ,Head Of Department 
Affiliation  National Institute of Ayurveda, Jaipur 
Address  Room number 114 ,department of panchakarma
new panchakarma building ,madhav vilas palace,joravar singh gate, amer road
Jaipur
RAJASTHAN
302002
India 
Phone  7030309088  
Fax    
Email  drsurendravedpathak50@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pooja  
Designation  M.D.Scholar  
Affiliation  National Institute of Ayurveda 
Address  Room number 111, pg seminar hall
new panchakarma building ,madhav vilas palace,joravar singh gate, amer road
Jaipur
RAJASTHAN
302002
India 
Phone  9680831002  
Fax    
Email  sandeepoojajangir@gmail.com  
 
Source of Monetary or Material Support  
National Institute Of Ayurveda, Jaipur Rajasthan Pin code 302002 
 
Primary Sponsor  
Name  National Institute Of Ayurveda  
Address  Madhav Vilas Palace Amer Road Jaipur Rajasthan India 
Type of Sponsor  Government 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 Pooja  National Institute of Ayurveda, Jaipur  OPD room number2 and IPD, PG Department of Panchakarma, National Institute of Ayurveda, Jaipur, Rajasthan
Jaipur
RAJASTHAN 		 9680831002

sandeepoojajangir@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, national institute of ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:L700||Acne vulgaris. Ayurveda Condition: YUVANAPIDAKA (MUKHADUSHIKA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-pAcana, पाचन (Procedure Reference: 17. Sushrut Samhita Dalhan commentary “Nibandh Sangrah” Chikitsa Sthan – 33/39 by Chaukhamba Subharti publication, Varanasi, Procedure details: 1 Pachan with Paniya kshar (Apamarg kshar in 1gm dose for initial 5 days in the morning ) 2.Mix Apamarg kshar(1gm) in Goghrit for Snehapan (starting dose 25 ml) in increasing dose till the occurance of Samyak Snehan lakshan .3 Sarvang Abhayang & Swedan Will be done on 2nd ,3rd ,4th 5th day of Samyak Snehan and on the day of Virechana. 4.Virechana with Trivritavleha.(dose 40-60gm) 5 Samsarjana Karma(according to Shudhi lakshan) )
(1) Medicine Name: apamarg kshar, Reference: 3. Ras Tarangini by Sadanand Sharma–“ksharvisheshadivigyaniya chaturdasa tarang” (14/71)., Route: Oral, Dosage Form: Kshara, Dose: 1(g), Frequency: od, Duration: 5 Days
2Comparator ArmProcedure-pAcana, पाचन (Procedure Reference: 17. Sushrut Samhita Dalhan commentary “Nibandh Sangrah” Chikitsa Sthan – 33/39 by Chaukhamba Subharti publication, Varanasi, Procedure details: 1. Pachan with Panchakol churn (3gm)For initial 5 days in the morning. 2.Snehapan with Goghrit(starting dose 25 ml) in increasing dose till the occurance of Samyak Snehan lakshan (no any Parkshep dravya added) 3.Sarvang Abhayang & Swedan Will be done on 2nd ,3rd ,4th 5th day of Samyak Snehan and on the day of Virechana. 4.Virechana with Trivritavleha(dose 40-60gm) 5Samsarjana Karma(according to Shudhi lakshan) )
(1) Medicine Name: panchakol churn, Reference: Brahmanand Tripathi Sharangdhar Sanhita –“Dipika” hindi commentary madhyam khanda 6/13-14 page no.-174 by Chaukhamba Subharti Parkashan, Varanasi., Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: od, Duration: 5 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1. Patients with cardinal symptoms of Yuvanpidika like:- Shalmli kantak aakar pidika, Ruja Yukta , Ghanta, Medogarbhata, toda ,srava.
2. Patients between 18-40 years of age group, irrespective of gender and religion.
3. Individual with mild to moderate symptoms of Aam.
4. Patient who are indicated for Virechana Karma.

 
 
ExclusionCriteria 
Details  1. Patients presenting with any serious disease having gross electrolyte imbalance and
low BT/CT value.
2. Patients who are unwilling for Virechana Karma.
3. Patient with any systemic disorders like Cardiac problem,Diabetes mellitus, Hypertension, Fever etc.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
changes in Global Acne Grading System.
Location Factor
Forehead 2
Right cheek 2
Left cheek 2
Nose 1
Chin 1
Chest and upper back 3

GAGS-A score of 1-18 is considered mild 19-30 moderate 31-38 severe and 39 very severe.

 		 day-0 , day- 5, day- 16th, after 1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in weight, lipid profile, skin lusture,bowel habit.  at the base line day and after completion of trail. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   10/01/2023 
Date of Study Completion (India) 28/07/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Acne vulgaris is a chronic inflammatory disease of the pilosebaceous follicles chracterised by comedons, papules,pustules and often scars. Chiefly on cheeks, chin, nose, forehead and upper trunk. Acne tends to appear earlier in female, due to later onset of puberty in males.

In Ayurvediya samhitas, there is a brief description available about Yuvanpidika. Which is a type of  Khudraroga. The early first description of Yuvanpidika is given in Sushrut samhita. In Charak samhita it is not describe as separate Vyadhi but in ‘Tristreshniya adhayaya’ Pidika roga is said to occur as Bahya roga marga ashrita roga (ch.su. 11/47) . Yuvanpidika is described by Acharya Sushruta as a separate  vyadhi in Nidan sthan 13 and Chikitsa sthan 20 under Khudra rogas. Likewise Acharya Madhav and Acharya Vagbhatt have described Yuvanpidika under Khudrarogas and not in separate chapter. Acharya Sushrut has mentioned 44, Acharya Vagbhatt 36, and Acharya Madhav has quoted 43 Khudra rogas.

 

“ शाल्मली कंटकाकारा पिटिका सरुजो धना :।
  मेदोगर्भा मुखे युनाम ताभ्याम् च मुखदूषिका:।।“                  (अ. ह. उ.  31/5 )

 

 

               Acharya Vagbhatt mentions the involvement of Vata, Kapha and Meda in the    development of Yuvanpidika. The involvement of Meda can be considered to show similarity with the involvement of sebum in acne. In Samhita various treatment of Yuvanpidika has been described but all can be concluded in two groups :-

1.Shodhan chikitsa- That is purification of body it includes Vaman,Virechana,   

   Nasya Karm and Raktmokshana.

     2.Saman chikitsa- That is conservative treatment by oral and tropical medicines. It includes Lepa, Upnaha and Kshar Karm.

WORK PLAN: -    

A.   GROUPING- After the complete examination and investigation, all the 30 patients will be randomly divided into two groups equally (15 patients in each  group) as below

                    GROUP-A

1.      Pachan with Paniya kshar (Apamarg kshar in 1 gm in 36ml water)  dose for initial 5 days in the morning )

 

2.      Mix Apamarg kshar(1gm) in Goghrit for Snehapan   (starting dose 25 ml) in increasing dose till the occurance of Samyak Snehan lakshan

.

3.      Sarvang Abhayang & Swedan  Will be done on 2nd ,3rd ,4th 5th day of Samyak Snehan and on the day of Virechana.

 

4.      Virechana with Trivritavleha

.                  (dose 40-60gm)

5.      Sansarjana Karma according to Shudhi Lakshan.

 

GROUP-B

      1.Pachan with Panchakol churn (3gm) with lukewarm water  For initial 5 days in the morning.

       

2. Snehapan with Goghrit  (starting dose 25 ml) in increasing                dose till the occurance of Samyak Snehan lakshan (no any Parkshep dravya added)

       

 3. Sarvang Abhayang & Swedan  Will be done on 2nd ,3rd ,4th 5th day of Samyak Snehan and on the day of Virechana.

      

4. Virechana with Trivritavleha

        (dose 40-60gm)

       5.Samsarjana Karma

 


 
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