| CTRI Number |
CTRI/2026/04/108902 [Registered on: 21/04/2026] Trial Registered Prospectively |
| Last Modified On: |
21/04/2026 |
| 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
|
Study on the effectiveness of kushmuladi Yog in Raktastambhan management |
|
Scientific Title of Study
|
Randomized Open Controlled Clinical Study To Evaluate The Raktastambhan Effect Of Kushmuladi Yog In The Management Of Raktarsh
With Special Reference To Bleeding Piles. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHRUTI ASHOKRAO PARASKAR |
| Designation |
PG SCHOLAR |
| Affiliation |
Yashwant ayurvedic college post graduate and research Center Kodoli Kolhapur |
| Address |
OPD No 4 Shalyatantra department Yashwant ayurvedic college post graduate and research Center Kodoli Kolhapur Maharashtra 416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9011532854 |
| Fax |
|
| Email |
paraskarshruti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaibhav Magar |
| Designation |
Associate professor |
| Affiliation |
Yashwant ayurvedic college post graduate and research Center Kodoli Kolhapur |
| Address |
OPD no 4 Shalyatantra department Yashwant ayurvedic college post graduate and research Center Kodoli Kolhapur Maharashtra 416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8600667796 |
| Fax |
|
| Email |
dr.vaibhav83magar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHRUTI ASHOKRAO PARASKAR |
| Designation |
PG SCHOLAR |
| Affiliation |
Yashwant ayurvedic college post graduate and research Center Kodoli Kolhapur |
| Address |
Yashwant ayurvedic college post graduate and research Center Kodoli Kolhapur Maharashtra 416114 India
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9011532854 |
| Fax |
|
| Email |
paraskarshruti@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant ayurvedic college post graduate and research Center Kodoli Kolhapur Maharashtra 416114 India |
|
|
Primary Sponsor
|
| Name |
Dr. Shruti Ashokrao Paraskar |
| Address |
OPD No 4 Shalyatantra department Yashwant ayurvedic college post graduate and research Center Kodoli Kolhapur Maharashtra 416114 India |
| 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 Shruti Ashokrao Paraskar |
Yashwant Dharmartha Rugnalaya Kodoli |
Opd No 4 Shalya Tantra Department 2nd Floor Yashwant ayurvedic college post graduate and research Center Kodoli Kolhapur Maharashtra
Kolhapur
MAHARASHTRA |
9011532854
paraskarshruti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Yashwant Ayurvedic College PGT and RC Kodoli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K00-K95||Diseases of the digestive system. Ayurveda Condition: RAKTAJA-ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Nagkehsar churna, Reference: Prof. Ravi Dutt Tripathi,Acharya Vidyadhar Shukla, Carakasamhitā of Agniveśa. Vol. 2. Edited with Hindi commentary, Delhi: Chaukhamba Sansk, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Navneet, Sharkara), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kushmuladi yog, Reference: Vangasena. Vangasen Samhita, Arsharogadhikar, Chapter 21, Shloka 75. In: Tripathi I, editor. 1st ed. Varanasi: Chaukhambha Krishnadas Academy; 2016. p. 283., Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Tandulodak), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Age group 20 to 50 years irrespective of gender
2 Patients having clinical features of Raktarsha
3 Patients with Duration of complaints less than 2 months
4 patient with 1 and 2 degree bleeding piles
5 patient with HB more than 10 gm
6 Pile mass palpated or seen by proctoscopy |
|
| ExclusionCriteria |
| Details |
1 patient with 3 degree and 4 degree bleeding piles
2 Piles associated with perianal abscess fissure fistula
3 Rectal proplase rectal polyp
4 Known case of ulcerative colitis ca rectum Hiv HbsAg tuberculosis
5 Piles with complications as Thrombosed
6 Patient with known case of associated systemic Disorders DM heamophillic disease
7 Pregnant and lactic mother
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the raktastambhan effect of Kushmuladi yog in Raktarsha w.s.r to
bleeding piles |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To review classical & contemporary literature on Kushmuladi yog with special
reference to its role in managing Raktarsha bleeding piles
2 To evaluate the therapeutic efficacy of Kushmuladi yog alleviating the signs
and symptoms associated with Raktarsha
3 To explore & compare the understanding of Arsha Vyadhi in both Ayurvedic
and modern medical science
4 To assess the clinical outcomes of the intervention within a 15day treatment
period |
7 days |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
06/05/2026 |
| 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
|
This study is randomized open controlled clinical study to evaluate the raktastambhan effect of kushmuladi yog in the management of raktarsh w.s.r to bleeding piles This study will be carried out in opd of Shalyatantra department of Yashwant Ayurvedic College and hospital Kodoli Observation will be drawn on the basis of symptoms after treatment given |