CTRI

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CTRI Number

CTRI/2025/04/085317 [Registered on: 22/04/2025] Trial Registered Prospectively

Last Modified On:

18/04/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Bruhatyadi Dhoopan and Neembadi Dhoopan Herbal Smoke Treatments to Reduce Pain After Surgery for Common Ano Rectal Problems

Scientific Title of Study

Randomized Controlled Clinical Trial Of Bruhatyadi Dhoopan And Neembadi Dhoopan For The Management Of Post Operative Pain In Benign Anorectal Diseases

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 Jigar Darji
Designation	PG Scholar
Affiliation	Parul University
Address	Parul Institute Of Ayurved Department Of Shalya Tantra 4th Floor Room No 403 Parul University Limda Vadodara GUJARAT 391760 India
Phone	6355536316
Fax
Email	jigardarji024@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Parikshit Shirode
Designation	Professor
Affiliation	Parul University
Address	Parul Institute Of Ayurved Department Of Shalya Tantra 4th Floor Room No 403 Parul University Limda, Vadodra Gujrat Vadodara GUJARAT 391760 India
Phone	9960063588
Fax
Email	parikshit.shirode260038@paruluniversity.ac.in

Details of Contact Person
Public Query

Name	Dr Parikshit Shirode
Designation	Professor
Affiliation	Parul University
Address	Parul Institute Of Ayurved Department Of Shalya Tantra 4th Floor Room No 403 Parul University Limda, Vadodra Gujrat Vadodara GUJARAT 391760 India
Phone	9960063588
Fax
Email	parikshit.shirode260038@paruluniversity.ac.in

Source of Monetary or Material Support

Parul Institute OF Ayurved Department Of Shalya Tantra 4th Floor Room No 403 Parul University Limda Vadodra Gujrat India 391760

Primary Sponsor

Name	Parul Institute Of Ayurved
Address	Parul Institute OF Ayurved Department Of Shalya Tantra 4th Floor Room No 403 Parul University Limda Vadodra Gujrat India 391760
Type of Sponsor	Research institution and hospital

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 Jigar Darji	Parul Institute Of Ayurved	Parul Institute of Ayurved Department of Shalya Tantra 4th Floor Room No 403 Parul University Limda Vadodra Gujrat Vadodara GUJARAT	6355536316 jigardarji024@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics committee Parul Institute Of Ayurved	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:K629\|\|Disease of anus and rectum, unspecified. Ayurveda Condition: SULAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Classical		(1) Medicine Name: Bruhati , Reference: Charak Samhita, Route: Topical, Dosage Form: Churna/ Powder, Dose: 7(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -Used As Dhoopan (2) Medicine Name: Ashwagandha , Reference: Charak Samhita, Route: Topical, Dosage Form: Churna/ Powder, Dose: 7(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -Used As Dhoopan (3) Medicine Name: Pippali , Reference: Charak Samhita, Route: Topical, Dosage Form: Churna/ Powder, Dose: 7(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -Used As Dhoopan (4) Medicine Name: Tulsi , Reference: Charak Samhita, Route: Topical, Dosage Form: Churna/ Powder, Dose: 7(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -Used As Dhoopan
2	Comparator Arm	Drug	Classical		(1) Medicine Name: Nimba, Reference: Shusrut Samhita, Route: Topical, Dosage Form: Churna/ Powder, Dose: 7(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -Used As Dhoopan (2) Medicine Name: Gour Sarsha, Reference: Shusrut Samhita , Route: Topical, Dosage Form: Churna/ Powder, Dose: 7(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -Used As Dhoopan (3) Medicine Name: Guggulu , Reference: Shusrut Samhita, Route: Topical, Dosage Form: Churna/ Powder, Dose: 7(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -Used As Dhoopan (4) Medicine Name: Vacha , Reference: Shusrut Samhita, Route: Topical, Dosage Form: Churna/ Powder, Dose: 7(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -Used As Dhoopan

Inclusion Criteria

Age From	20.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1.Patients undergone anorectal surgeries and suffering from pain of intensity 7 to 10 on vas scale will be enrolled for Dhoopan procedure. 2.Patients wilfully giving well informed written consent. 3.Age group between- 20 years to 60 years.

ExclusionCriteria

Details

1.Patients with disorders like Malignancy, Syphilis, Tuberculosis, Leprosy
2. HIV+ve, HBsAg+ve, VDRL+ve,
3.Patient with uncontrolled diabetes mellitus and hypertension.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Not Applicable

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Post Operative Pain Reductions Without Use of Oral Pain Killers	from commencement of pain reduction in between 1 hours, 6 hours ,12 hours ,24 hours postoperatively for 5 days post operative days

Secondary Outcome

Outcome	TimePoints
No Gastric Acid Reflux Will Be Seen Due To intake No Need Of Painkiller In Post Operative Period	from commencement of pain reduction in between 1 hours, 6 hours ,12 hours ,24 hours postoperatively for 5 days post operative days

Target Sample Size

Total Sample Size="30"
Sample Size from India="30"
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)

09/05/2025

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="0"
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

Ano-rectal conditions like hemorrhoids, fistula in ano, chronic fissure associated with sentinel tag are common conditions requiring surgical excision followed by significant post operative pain, making effective pain management crucial for patient recovery.

Conventional pain medications may have side effects such as gastrointestinal issues and dependency, necessitating safer, alternative treatments. Incorporating traditional medicine with modern post-surgical care could provide a more comprehensive approach to pain management.Ayurvedic formulations like Bruhatyadi Dhoopan and Neembadi Dhoopan may offer natural and holistic pain relief options without adverse effects, but clinical evidence is lacking.This study aims to evaluate the clinical efficacy of Bruhatyadi Dhoopan and Neembadi Dhoopan for managment of post operative ano-rectal pain.The study will assess pain reduction (VAS scale), patient satisfaction, and adverse effects over seven days post-surgery.

Hence the need and uniqueness of study.