| CTRI Number |
CTRI/2025/08/092862 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A Comparative Clinical Trial To Assess The Effect Of Piccha Basti And Balaguduchyadi Taila Matra Basti In The Managment Of Abnormal Uterine Bleeding |
|
Scientific Title of Study
|
A RANDOMIZED OPEN LABEL COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF PICCHA BASTI WITH BALAGUDUCCHYADI TAILA MATRA BASTI IN THE MANAGEMENT OF ASRIGDAR W.S.R. ABNORMAL UTERINE BLEEDING. |
| 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 Priya |
| Designation |
MS Scholar Stree Roga Prasuti Tantra |
| Affiliation |
Institute For Ayurved Studies And Research |
| Address |
OPD NO 15 Department Of Stree Roga Prasuti Tantra Institute For Ayurved Studies And Research Umri Road Sector 8 Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
8882130575 |
| Fax |
|
| Email |
priyapanchal8335@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jitesh Kumar Panda |
| Designation |
Chairperson |
| Affiliation |
Institute For Ayurved Studies And Research |
| Address |
Room No 112 PG Department Of Stree Roga Prasuti Tantra Institute For Ayurved Studies And Research Umri Road Sector 8 Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
9896033056 |
| Fax |
|
| Email |
drjk67@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priya |
| Designation |
MS Scholar Stree Roga Prasuti Tantra |
| Affiliation |
Institute For Ayurved Studies And Research |
| Address |
OPD NO 15 Department Of Stree Roga Prasuti Tantra Institute For Ayurved Studies And Research Umri Road Sector 8 Kurukshetra Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
8882130575 |
| Fax |
|
| Email |
priyapanchal8335@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute For Ayurved Studies And Research Sector 8 Umri Road Kurukshetra PIN 136118 Haryana India |
|
|
Primary Sponsor
|
| Name |
Institute For Ayurved Studies And Research |
| Address |
Sector 8 Umri Road Kurukshetra PIN 136118 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Priya |
Institute For Ayurved Studies And Research |
OPD NO 15 Department Of Stree Roga Prasuti Tantra Institute For Ayurved Studies And Research Umri Road Sector 8 Kurukshetra Haryana
Kurukshetra
HARYANA |
8882130575
priyapanchal8335@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC SKAU KURUKSHETRA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N719||Inflammatory disease of uterus, unspecified. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: CHARAK SAMHITA, Procedure details: 20 Patients Will Be Treated With Piccha Basti After Cessation Of Menses For 8 Days For 3 Consecutive Cycles Dosage 300 ML)
(1) Medicine Name: Piccha Basti, Reference: Charak Chikitsa Chapter 14 Shloka 225 To 228, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 300(ml), Frequency: od, Duration: 8 Days | | 2 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Charak Samhita, Procedure details: 20 Patients Will Be Treated With Balaguduchyadi Taila Matra Basti After The Cessation Of Menses For 8 Days For 3 Consecutive Cycles)
(1) Medicine Name: Balaguduchyadi Taila , Reference: Charak Siddhi Sthan Chapter 3 Shloka 16 To 19, Route: Rectal, Dosage Form: Taila, Dose: 60(ml), Frequency: od, Duration: 8 Days |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Excessive Menstrual Bleeding
Intermenstrual Bleeding
Prolonged Bleeding
Patients Willing To Participate And Provide Informed Consent In Trial |
|
| ExclusionCriteria |
| Details |
Uterine And Pelvic Pathology
Use Of IUCD
Bleeding Caused By Miscarriage
Inevitable Abortion
Cardiovascular Renal Coagulation Chronic Systemic Disease
Bleeding Site Other Than Uterus
Develop Condition Which May Require Other Treatment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Improve The Grading Of Menorrhagia And Duration Of Bleeding |
Follow Up Will Be Done On 60 90 120 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement In The Haemoglobin Level
Improvement In The Endometrial Thickness |
Follow Up Will Be Done On 60 90 120 Days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/12/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
ABNORMAL UTERINE BLEEDING DEFINED AS ANY DEVIATION FROM THE NORMAL MENSTRUAL CYCLE IN TERMS OF FREQUENCY DURATION REGULARITY OR VOLUME OF BLOOD FLOW THAT IS NOT RELATED TO PREGNANCY. IT AFFECTS WOMENS PHYSICAL,SOCIAL,EMOTIONAL WELL BEING.WHILE CONVENTIONAL TREATMENTS OFFERS SYMPTOMATIC RELIEF THEY ARE ASSOCIATED WITH SIDE EFFECTS AND MAY NOT BE SUITABLE FOR ALL PATIENTS.THIS RANDOMIZATION OPEN LABEL COMPARATIVE CLINICAL STUDY IS TO EVALUATE THE EFFICACY OF PICCHA BASTI WITH BALAGUDUCHYADI TAILA MATRA BASTI .THE STUDY INVOLVES 40 PARTICIPANTS WHO ARE DIAGNOSED WITH AUB BASED ON CLINICAL EVALUATION AND SUPPORTING INVESTIGATIONS.PICCHA BASTI KNOWN FOR ITS ASTRINGENT PROPERTY AND BALAGUCHYADI TAILA FOR A NUTRITIVE AND VATA PACIFYING AYURVEDIC FORMULATION FOR MANAGING ASRIGDAR.THIS WILL BE ADMINISTERED FOR 3 MONTHS AIMING TO REDUCE SYMPTOMS SUCH AS EXCESSIVE MENSTRUAL BLEEDING,INTERMENSTRUAL BLEEDING,AND OTHER SYMPTOMS.OUTCOME MEASURE WILL INCLUDE BOTH SUBJECTIVE AND OBJECTIVE PARAMETERS .THIS STUDY WILL OFFER A POTENTIALLY SAFER ALTERNATIVE TO CONVENTIONAL TREATMENT. |