| CTRI Number |
CTRI/2025/07/089991 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
01/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Yashtimadhu and trifla Ghrita pichu in the management of parikartika. |
|
Scientific Title of Study
|
A comparative clinical evaluation of the efficacy of Yashtimadhu Ghrita Pichu and Trifala Ghrita pichu in the management of parikartika with special Reference to Fissure in ano |
| 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 Ved Prakash Sharma |
| Designation |
P G Scholar |
| Affiliation |
S. G. M. P. G. Ayurvedic college and hospital |
| Address |
Head of department Shalya Tantra room no 103 S G M P G Ayurvedic college and hospital Saheri Ghazipur
Head of department Shalya Tantra Room no 103 S G M P G Ayurvedic College and Hospital Saheri Ghazipur
Ghazipur
UTTAR PRADESH
233302
India |
| Phone |
9838437356 |
| Fax |
|
| Email |
drvedsharma8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surendra Kumar Mishra |
| Designation |
Professor |
| Affiliation |
S. G. M. P. G. Ayurvedic college and hospital |
| Address |
Head Of Department Shalya Tantra Room no 103 S G M P G Ayurvedic college and hospital Saheri Ghazipur
Head Of Department Shalya Tantra Room no 103 S G M P G Ayurvedic College and Hospital Saheri Ghazipur
Ghazipur
UTTAR PRADESH
233302
India |
| Phone |
9838437356 |
| Fax |
|
| Email |
drshyamlal80@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ved Prakash Sharma |
| Designation |
P G Scholar |
| Affiliation |
S. G. M. P. G. Ayurvedic college and hospital |
| Address |
Department of Shalya Tantra Room no 103 S G M P G Ayurvedic college and hospital Saheri Ghazipur
Head Of Department Shalya Tantra Room no 103 S G M P G Ayurvedic College and Hospital Saheri Ghazipur
Ghazipur
UTTAR PRADESH
233302
India |
| Phone |
9838437356 |
| Fax |
|
| Email |
drvedsharma8@gmail.com |
|
|
Source of Monetary or Material Support
|
| S G M P G Ayurvedic College and Hospital Saheri Ghazipur Uttar Pradesh India 233302 |
|
|
Primary Sponsor
|
| Name |
Dr Ved Prakash Sharma |
| Address |
S G M P G Ayurvedic college and Hospital Saheri Ghazipur Uttar Pradesh India 233302 |
| Type of Sponsor |
Other [Private Ayurvedic College] |
|
|
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 Vedparakash Sharma |
S. G. M. P. G. Ayurvedic College and Hospital |
OPD Shalya tantra Department
Ghazipur
UTTAR PRADESH |
9838437356
drvedsharma8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC S.G.M.P.G. Ayurvedic College Saheri Ghazipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K605||Anorectal fistula. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Yashtimadhu Ghrita, Reference: Bhaishajya Ratnawali saddhovranadhikar48 slokh 01, Route: Rectal, Dosage Form: Ghrita, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Triphala Grita, Reference: ashtanga Hridah sutra sthan 118a annaswarup vigyaneeya, Route: Rectal, Dosage Form: Ghrita, Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 1 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1- The patient of age group between 18-60 years.
2- Patients with either sex were selected.
3- Patients with no pre-existing serious medical condition.
4- Person currently taking no other medication.
|
|
| ExclusionCriteria |
| Details |
1- Age below 18 years and above 60 years.
2- Any serious systemic disorders like T.B, HTN, DM.
3- Pregnant women.
4- Mentally sick patient.
5- HIV, HBsAg, HCV Positive cases.
6- Fissure in Ano secondary to Ulcerative colitis, Crohn’s disease, Syphilis.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The patient will be diagnosed on the basis of history, signs, symptoms and local examination of Parikartika & presence of features of Chronic fissure in ano. |
2 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment was made with the following parameters:
1. Pain in anal region during defecation
2. Duration of burning sensation in anal region during defecation
3. Constipation
4. Bleeding peranum i.e. stools streaked with blood
5. Ulcer healing – Edge, floor, margin
6. Tenderness on D.R.E. (Digital rectal examination) for the assessment of sphincter tone anal canal after application of Ghrita
|
2 month |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
20/07/2025 |
| 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="2"
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
|
The whole research work will be
summarized and conclusion will be made on the basis of the observation which
will be done on the subjective and objective parameters. Result will be
analyzed statically & discussed accordingly. |