| CTRI Number |
CTRI/2025/08/092998 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Controlled Clinical Trial To Evaluate The Effect Of Mudgadya Ghrit Uttarbasti and Apamarg Kshar Taila Uttarbasti in the Management of Adenomyosis Or Vataja Asrigdar |
|
Scientific Title of Study
|
A Randomized Open Label Controlled Clinical Study to Evaluate the Efficacy of Mudgadya Ghrit Uttarbasti and Apamarg Kshar Taila Uttarbasti in the Management of Vataja Asrigdar w.s.r Adenomyosis |
| 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 Prajkta Gajanan Chaudhari |
| Designation |
PG 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 |
9373147883 |
| Fax |
|
| Email |
prajktachaudhari799@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 Kurukshetra Haryana
Kurukshetra HARYANA 136118 India |
| Phone |
9896033056 |
| Fax |
|
| Email |
drjk67@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Prajkta Gajanan Chaudhari |
| Designation |
PG 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 |
9373147883 |
| Fax |
|
| Email |
prajktachaudhari799@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute for Ayurved Studies and Research Shri Krishna Ayush University Sector 8 Umri Road Kurukshetra |
|
|
Primary Sponsor
|
| Name |
Institute for Ayurved Studies and Research |
| Address |
Sector 8 Umri Road Kurukshetra Pin136118 |
| 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 Prajkta Gajanan Chaudhari |
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 |
9373147883
prajktachaudhari799@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Shri Krishna Ayush University 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 | - | uttarabastikarma, उत्तरबस्तिकर्म | (Procedure Reference: Charak Samhita , Procedure details: 20 patients will be treated with Mudgadya Ghrit Uttarbasti after complete cessation of menses for 3 days for 3 consecutive cycles Dosage 5 ml) (1) Medicine Name: Mudgadya Ghrit , Reference: Yogaratnakar Chapter Stree Rogadhikar Pradar Roga Chikitsa Verse 1 , Route: Vaginal, Dosage Form: Ghrita, Dose: 5(ml), Frequency: od, Duration: 3 Months | | 2 | Comparator Arm | Procedure | - | uttara-bastiH, उत्तर-बस्तिः | (Procedure Reference: Charak Samhita , Procedure details: 20 patient will be treated with Apamarg kshar Taila Uttarbasti after complete cessation of menses for 3 days for 3 consecutive cycles
Dosage 5 ml) (1) Medicine Name: Apamarg Kshar Taila, Reference: Chakradatta Karnarog Chikitsa Chapter 57/25, Route: Vaginal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 3 Months |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1 Married female Patients of age between 21 to 50years
2 Patients willing to participate in Clinical Trial
3 Patient having Heamoglobin greater than 7gm percent
4 Patients having symptoms of AUB or frothy bleeding or Menorrhagia with one all the following symptoms such as dysmenorrhea dyspareunia and known case of Adenomyosis confirmed by any diagnostic technique
5 Patients are Yogya for Uttarbasti procedure
|
|
| ExclusionCriteria |
| Details |
1 All pregnant women
2 Patients not willing for trial
3 Patient having Systemic Disease like Diabetes FBS greater than 125 mg per dl,Hypertension greater than 140 by 90mm of Hg,Severe Anemia Hb less than 7 gm percent
4 Patients having coagulation disorders, cardiovascular disorders, Cerebrovascular accidents
5 Patients suffering from Malignancy
6 Patient with congenital anamoly of reproductive tract
7 Acute inflammatory disease like Sexual Transmitted Disease like HIV, VDRL,HBsAg, HCV positive females
8 Patient Ayogya for Uttarbasti procedure
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1 To improve the grading of Menorrhagia |
Follow up will be done on 30,60,90,120 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Improvement in the Heamoglobin level
2 To resolve MUSA Criteria for Adenomyosis |
Follow up will be done on 90 day & 1 more follow up on 120 day After completion of trail |
|
|
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 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
Modification(s)
|
PRIMARY PURPOSE IS TREATMENT ADENOMYOSIS IS A CONDITION WHERE THERE IS A INGROWTH OF ENDOMETRIUM DIRECTLY INTO THE MYOMETRIUM. PREVALENCE OF ADENOMYOSIS IN CASE OF ENDOMETRIOSIS IS 70 PERCENT AND THE PREVALENCE IS FOUND TO BE 23.5 PERCENT IN PATIENTS WHO HAD COMPLAIN OF MENORRHAGIA 70 PERCENT FOLLOWED BY DYSMENORRHEA 30 PERCENT. THE PATIENTS ARE USUALLY PAROUS 90 PERCENT WITH ABOVE AGE 40. THE PATIENT WITH ADENOMYOSIS USUALLY PRESENT WITH MENORRHAGIA, DYSMENORRHEA, DYSPAREUNIA , INCREASE THE FREQUENCY OF MICTURITION AND INFERTILITY. IN MODERN MEDICINE, THE MAIN OBJECTIVE OF MANAGEMENT IS RELIEF FROM PAIN AND REDUCTION OF EXCESSIVE MENSTRUAL BLEEDING. MOSTLY USE NSAIDS AND HORMONAL THERAPIES AND LAST OPTION IS HYSTERECTOMY. HOWEVER LONG TERM USE OF THESE MEDICATIONS MAY LEAD TO ADVERSE EFFECTS ON WOMENS HEALTH. AYURVEDA AS A HOLISTIC SCIENCE AND WAY OF LIVING OFFERS PROMISING ALTERNATIVE TREATMENT MODALITIES THAT CAN POTENTIALLY REPLACE OR COMPLEMENT ALLOPATHIC APPROACHES WHILE MINIMIZING HARMFUL SIDE EFFECTS. IN VIEW OF THIS EFFECT OF MUDGADYA GHRIT UTTARBASTI AND APAMARG KSHAR TAILA UTTARBASTI IN THE MANAGEMENT OF ADENOMYOSIS WSR VATAJA ASRIGDAR. THIS STUDY INVOLVES 40 PATIENTS. THESE 40 PATIENTS ARE DIAGNOSED WITH ADENOMYOSIS BASED ON CLINICAL EVALUATION AND SUPPORTING INVESTIGATIONS. MUDGADYA GHRITA AND APAMARG KSHAR TAILA ARE DIVIDED INTO 2 GROUPS . THIS WILL BE ADMINISTERED FOR 3 MONTHS IN FORM OF UTTARBASTI AFTER CESSATION OF MENSES AIMING TO RESOLVE THE SYMPTOMS OF ADENOMYOSIS SUCH AS MENORRHAGIA, DYSMENORRHEA AND OTHER SYMPTOMS RESOLVE MUSA CRITERIA FOR ADENOMYOSIS . OUTCOME MEASURE WILL INCLUDES BOTH SUBJECTIVE AND OBJECTIVE PARAMETERS. ALTHOUGH, ADENOMYOSIS IS NOT DIRECTLY CORRELATED WITH ANY DISEASE IN AYURVEDA BUT ON THE BASIS OF SYMPTOMS ADENOMYOSIS CAN BE CORRELATED WITH VATAJA ASRIGDAR. THIS STUDY AS TO PROVIDE AN EASY AND POTENTIALLY SAFER ALTERNATIVE TO CONVENTIONAL TREATMENT. |