| CTRI Number |
CTRI/2025/05/086935 [Registered on: 14/05/2025] Trial Registered Prospectively |
| Last Modified On: |
09/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Use of Nimbapatradi varti in Paatit gud vidradhi (Ano rectal abscess) |
|
Scientific Title of Study
|
Clinical Study on Nimbapatradi varti in Paatit gud vidradhi w.s.r. to Anorectal abscess |
| 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 Shreya Maurya |
| Designation |
MS PG Scholar |
| Affiliation |
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya khurja Bulandshahr |
| Address |
OPD no 5 Department of Shalya tantra Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulanshahr
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
9452802646 |
| Fax |
|
| Email |
shreya021993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Elizabeth P John |
| Designation |
MS Ayurveda HOD of Shalya Tantra |
| Affiliation |
Vaidya Yagya Dutt Sharma Ayurved M |
| Address |
OPD no 5 Department of Shalya tantra Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulanshahr
Bulandshahar
UTTAR PRADESH
203131
India |
| Phone |
9448345918 |
| Fax |
|
| Email |
elizajhn@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Elizabeth P John |
| Designation |
MS Ayurveda HOD of Shalya Tantra |
| Affiliation |
Vaidya Yagya Dutt Sharma Ayurved M |
| Address |
OPD no 5 Department of Shalya tantra Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulanshahr
UTTAR PRADESH
203131
India |
| Phone |
9448345918 |
| Fax |
|
| Email |
elizajhn@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr Uttar Pradesh 203131 |
|
|
Primary Sponsor
|
| Name |
Dr Shreya Maurya |
| Address |
OPD no 5 Department of Shalya Tantra Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr Uttar Pradesh 203131 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shreya Maurya |
Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr |
OPD no 5 Department of Shalya Tantra Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja
Bulandshahar
UTTAR PRADESH |
9452802646
shreya021993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Vaidya Yagya Dutt Sharma Ayurved Mahavidyalaya Khurja Bulandshahr Uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K612||Anorectal abscess. Ayurveda Condition: GUDAJAVIDRADHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | vartiH, वर्तिः | (Procedure Reference: Sushrutha chikitsa adhyaya chapter 1 shloka no 55, Procedure details: For 1 month
once a day procedure will be done 3 steps
Purva, Pradhana and Paschat karma.
PURVA KARMA- In lithotomy position of Paatit Gud-vidradhi patients, washing the area with normal saline, to remove any residual pus & debris.
PRADHAN KARMA- With the help of artery forcep, Nimbapatradi varti will be loosely packed into the Paatit
Gud vidradhi locally.
PASCHAT KARMA- Sterile dressing and bandaging will be done.
follow up will be done once a week)
(1) Medicine Name: Nimbapatradi, Reference: Bhaishajya Ratnavali chapter 47 shloka no 45, Route: Topical, Dosage Form: Varti/ Suppository, Dose: 5(g), Frequency: od, Duration: 1 Months |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient who has given consent for the clinical trial.
Incised case of single ano-rectal abscess(Paatit Gud vidradhi).
Incised case of ano-rectal abscess of size Upto 5 cm2
Patients of age group above 16 & below 60 years,both sex. |
|
| ExclusionCriteria |
| Details |
Patient of age group below 16 & above 60 will be excluded.
Patients having ano rectal disorders like anal fissure, anal fistula, thrombosed external hemorrhoids, rectal
prolapse.
Patients having Systematic Diseases (D.M & HTN),Tuberculosis & known case of HIV/AIDS.
Pregnant or Lactating Women.
Patients having Crohn’s disease and Ca rectum. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in inflammation of abscess |
1 month
The trial drug will be given for 1 month and follow up will be done after 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Relief in pain, discharge & swelling of paatit gud vidradhi |
After analyzing all the parameters the result will be assessed on the basis of symptomatic relief & improvement.
Partially improvement after 1 week - patient get 30 percent relief from sign & symptoms Improvement after 2 weeks Patient get 40-50 percent relief from sign & symptoms Improvement after 3 weeks patient get 60-80 percent relief from sign & symptoms
Cured after 1 month/ 4 weeks patient get 80-100 percent relief from sign & symptoms |
|
|
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 3 |
|
Date of First Enrollment (India)
|
15/06/2025 |
| 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="10"
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
|
Due to various factors, when vitiated doshas enter
the Dhatus like Twak, Rakta, Mamsa, Meda and Asthi, it gradually causes pain and severe swelling (sopha)
leading to the formation of Vidradhi. In the Pakwaawastha(suppurated stage), which should be treated as vrana
, mentioned in Vidradhi Chikitsa adhyaya. There are several drugs for paatit gud vidradhi but here I have chosen Nimbapatradi varti for its
antimicrobial, anti-inflammatory, and healing properties. Therefore I have selected 60 patients aged between 16-60 years, patient should be selected on the basis of inclusion and exclusion criteria . The trial will be of 1 month and follow up will be done after every 7 days. Cured after 1 month patient gets 80-100 percent relief from sign and symptoms |