| CTRI Number |
CTRI/2025/08/093271 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
18/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical study to evaluate effect of shonithastapana ksheera basti with pushyanuga churna and sarasijamakarandadi churna in Abnormal uterine bleeding |
|
Scientific Title of Study
|
A Comparative Clinical Study to Evaluate the effect of SARASIJAMAKARANDADI CHURNA AND PUSHYANUGA CHURNA with SHONITASTHAPANA GANA SIDDHA KSHEERA BASTI in Management of ASRIGDARA with special reference to DYSFUNCTIONAL 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 Chaitra N |
| Designation |
Assistant professor |
| Affiliation |
Sri kalabyraweshwara ayurvedic medical college hospital research center |
| Address |
Department of Prasuti Tantra and Stree Roga
Sri kalabyraweshwara ayurvedic medical college hospital research center
RPC layout, Hampi Nagar vijaynagar
Bangalore KARNATAKA 560104 India |
| Phone |
8123972387 |
| Fax |
|
| Email |
chaitranagendra81@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Chaitra N |
| Designation |
Assistant professor |
| Affiliation |
Sri kalabyraweshwara ayurvedic medical college hospital research center |
| Address |
Department of prasuti tantra stree roga
Sri kalabyraweshwara ayurvedic medical college hospital research center
RPC layout, Hampi Nagar Vijayanagar Bangalore
Bangalore KARNATAKA 560104 India |
| Phone |
8123972387 |
| Fax |
|
| Email |
chaitranagendra81@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Chaitra N |
| Designation |
Assistant professor |
| Affiliation |
Sri kalabyraweshwara ayurvedic medical college hospital research center |
| Address |
Department of prasuti tantra stree roga
Sri kalabyraweshwara ayurvedic medical college hospital research center
RPC layout Hampi Nagar vijaynagar
Bangalore KARNATAKA 560104 India |
| Phone |
8123972387 |
| Fax |
|
| Email |
chaitranagendra81@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri kalabyraweshwara ayurvedic medical college hospital research |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [] |
|
|
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 ChaitraN |
Sri kalabyraweshwara ayurvedic medical college hospital research center |
Department of prasuti tantra stree roga
10 pipeline road RPC layout hampi Nagar vijaynagar bangalore 104 Bangalore KARNATAKA |
8123972387
chaitranagendra81@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKAMCH&RC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N920||Excessive and frequent menstruation with regular cycle. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | Basti karma | (Procedure Reference: Charaka, Procedure details: Shonithastapana Ksheera basti -yoga basti) (1) Medicine Name: Sarasijamakarandadi churna , Reference: Sahasrayoga , Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: bd, Duration: 1 Months | | 2 | Intervention Arm | Procedure | - | Bastikarma | (Procedure Reference: Charaka, Procedure details: Shonithastapana Ksheera basti) (1) Medicine Name: Sarasijamakarandadi churna, Reference: Sahsrayoga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: bd, Duration: 1 Months |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
Patients between the age group of 18 to 50 years
Patients with lakshanas of asrigdara
History of excessive bleeding for at least two cycles
|
|
| ExclusionCriteria |
| Details |
Patients with history of any systemic disorders and endocrinal disorders which interfere with the course of treatment
Patients using intrauterine contraceptive device
Patients with the history of any anatomical uterine pathology or any growth
Incomplete abortion
Patients below 18 years and above 50 years
Bleeding other than that of uterine origin
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Reduce in excessive bleeding |
Treatment duration -3 consecutive cycles
Yoga basti and shamana ousadi
Follow up after 3 cycles |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
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)
|
15/12/2025 |
| 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="5" Months="0" 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
|
Asrigdara is one of the most common gynaecological problems It refers to pradirana ie excessive flow of asrik It is the excessive or prolonged blood loss during menstruation with or without bleeding in intermenstrual period. Ayurvedic classics have mentioned various nidanas based on which the respective doshas get vitiated predominantly apana vayu vitiation takes place which affects the reproductive system and increases the artava pramana in the garbhashaya gata siras Asrigdara is of four types vataja pittaja, kaphaja and sannipataja and the lakshanas are based on the dosha predominance. According to Acharya Sushruta there is angamarda and pain symptoms present in all types of asrigdara with excessive vaginal bleeding that is seen as a samanya lakshana Complications include dourbalya, bharama murchha tama trishna daha pandu and tandra which usually seen in this condition It can be correlated to the Dysfunctional uterine bleeding which is defined as a state of abnormal uterine bleeding without any clinically detectable organic systemic iatrogenic cause where pelvic pathology like tumour inflammation or pregnancy is excluded About 10-30 percentage of reproductive aged women suffer from this condition and the prevalence increases during menarche and peri-menopausal period This condition can cause many complications like anaemia and infertility, general debility, lack of concentration discomfort etc which can hamper day to day routine activities It is observed that sharp increase in the incidence today due to lifestyle food habits and stress Management of Dysfunctional uterine bleeding includes hormonal medications including oral contraceptives non hormonal medications including NSAIDs and tranexamic acid, intrauterine devices and surgical management Medical management in contemporary science has potential side effects and most of the cases end-up in surgical intervention. According to studies hysterectomy operations are primarily performed for benign indications such as excessive menstrual bleeding, fibroids/cysts, uterine disorder and uterine prolapse in India. It is reported that some of these operations were lifesaving, some were only meant for treating nonfatal but severe conditions and some are unnecessary. It is indicated that many of these causes were considered to be treatable and surgery could be avoided Hence there is a need to treat such cases with medicines that are potent enough to regularize the menstrual cycle with a normal flow and avoid surgical intervention In the present study attempt is made to evalaute the efficacy of shonitasthapana gana siddha ksheera basti and shamanaousadis like Sarasija Makarandadi churna and Pushyanuga churna in Asrigdara
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