| CTRI Number |
CTRI/2025/02/080050 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Management of Heavy Menstrual Bleeding (Menorrhagia) and Hemoglobin Level through Panchakarma Therapy (Basti Karma) and Ayurvedic Medicine |
|
Scientific Title of Study
|
Comparative Efficacy of Chandanadi Basti along with Pradarantaka Lauha and Pradarantaka Lauha Alone on Hemoglobin level in Patients with Raktapradara (w.s.r Menorrhagia) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ayushi Gupta |
| Designation |
PG Scholar |
| Affiliation |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Department of Panchakarma, Ayurvedic and Unani Tibbia College and Hospital, Ajmal Khan Road, Karol Bagh, New Delhi
Central
DELHI
110005
India |
| Phone |
9811660326 |
| Fax |
|
| Email |
dr.ayushiigupta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitin Jindal |
| Designation |
Associate Professor |
| Affiliation |
Ayurvedic and Unani Tibbia College And Hospital |
| Address |
Department of Panchakarma, Ayurvedic and Unani Tibbia College and Hospital, Ajmal Khan Road, Karol Bagh, New Delhi
Central
DELHI
110005
India |
| Phone |
9811765501 |
| Fax |
|
| Email |
nitjin2005@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ayushi Gupta |
| Designation |
PG Scholar |
| Affiliation |
Ayurvedic and Unani Tibbia College And Hospital |
| Address |
Department of Panchakarma, Ayurvedic and Unani Tibbia College and Hospital, Ajmal Khan Road, Karol Bagh, New Delhi
Central
DELHI
110005
India |
| Phone |
9811660326 |
| Fax |
|
| Email |
dr.ayushiigupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Panchakarma, Ayurvedic and Unani Tibbia College and Hospital, Karol Bagh, New Delhi-110005 |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
Ajmal Khan Road, Block 56, Karol Bagh, New Delhi-110005 |
| Type of Sponsor |
Government medical 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 Ayushi Gupta |
Ayurvedic and Unani Tibbia College and Hospital |
OPD no. 2, Department of Panchakarma, A and U Tibbia College and Hospital, Ajmal Khan Road, Block 56, Karol Bagh, New Delhi 110005
Central
DELHI |
9811660326
dr.ayushiigupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Ayurvedic and Unani Tibbia College and Hospital |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:N92||Excessive, frequent and irregularmenstruation. Ayurveda Condition: ASRUGDARAH/RAKTAPRADARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | yoga-bastiH, योग-बस्तिः | (Procedure Reference: Ch.Si. 3/48-52, Procedure details: Atleast 2 courses of YOGA BASTI (5-8days) will be administered after completion of menstrual cycle. CHANDANADI NIRUHA BASTI and Anuvasana basti with MURCHITA GHRITAM
along with shamana aushadhi PRADARANTAK LAUHA for 90 days.)
(1) Medicine Name: PRADARANTAK LAUHA, Reference: B.R.stri rogadhikara 75-79, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: bd, Duration: 90 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: PRADARANTAK LAUHA, Reference: Bhaishajaya Ratnavali Chapter stri rogadhikara, shloka no 75-79, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Water), Additional Information: -NIL |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Heavy menstrual flow greater than 80ml/cycle
2. Hemoglobin level 7.0-10.9gm/dl
3. Patient willing to provide written informed consent |
|
| ExclusionCriteria |
| Details |
1. Patients who are contraindicated for Niruha basti and Anuvasana basti, will not be included in Group A.
2. Pregnant women and lactating mothers.
3. Known cases of aplastic anemia, sickle cell anemia, thalassemia, autoimmune hemolytic anemia, chronic blood loss anemia like gastrointestinal bleeding or any infection or any documented history of blood disorders.
4. Patients with co-morbid conditions such as Hypertension (systolic greater than 150 mm Hg and diastolic greater than 100 mm Hg despite antihypertensive) and Diabetes Mellitus (having HbA1c greater than 7.0% despite anti-diabetic medications).
5. Patients planning to undergo or already had any gynecological surgery.
6. Patients suffering from major illnesses such as malignancy, Ascites, Intestinal
perforation, Intestinal obstruction etc.
7. Patients with severe impairment in LFT and KFT.
8. Patients on antiretroviral, anti-tuberculosis, anticoagulants, anticonvulsants,
psychotropic medications, cardiovascular agents, or immunosuppressants.
9. Excluding patients who have uterine fibroids that are specifically responsible for
causing bleeding per vagina.
10. Causes of bleeding per vagina such as polyps, adenomyosis, (malignancy, and hyperplasia, as ruled out through a per-speculum examination, USG pelvis, or other symptoms) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome will be the change in hemoglobin level from baseline in patients with Raktapradara (w.s.r Menorrhagia) ( for both the group A and B) |
The primary outcome will be the change in hemoglobin level from baseline in patients with Raktapradara (w.s.r Menorrhagia) ( for both the group A and B) at 30, 60 and 90th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome will be the change in the grading of clinical features of Raktapradara (w.s.r Menorrhagia) & Assessment of menstrual blood loss from the baseline. |
Secondary outcomes will be measured by through grading system of clinical features of Raktapradara (w.s.r Menorrhagia) & Menstrual blood loss will be assessed by using the PBAC (Pictorial Blood Loss Assessment Chart) at 90th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
17/03/2025 |
| 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
|
Raktapradara (Menorrhagia) is a prevalent gynecological issue, categorized as Yoni-garbhashayvikar in Ayurveda. Major symptoms include Artava ati-pravrutti (excessive bleeding greater than 80 ml per cycle), Deergha kala pravrutti (prolonged duration greater than 7 days), Daha (burning sensation), and Adho vankshana pradesha shoola (pain in the lower abdomen). This heavy menstrual bleeding can lead to Anemia (Pandu), which manifests with symptoms such as Durbalya (Weakness), Shrama (Fatigue), Shweta avabhasata (Pallor), Bhrama (Giddiness), Shwasa (Breathlessness), and Annanaabhilasha (Loss of appetite). These conditions significantly affect a woman’s physical, social, and emotional quality of life.
Acharya Charaka mentioned Chandanadi Basti in Siddhi Sthana and also Bhaishajya Ratnavali in Stri Rogadhikara advocates the use of Pradarantaka Lauha in managing Pandu and Raktapradara.
Chandanadi Basti combines Raktasthapaka (hemostatic) action with Vatapitta Shamaka (balancing Vata and Pitta), Garbhashaya Balya (uterine tonics), and Samprapti Vighattan (pathogenesis breakdown), aiming to control or cure both Pandu and Raktapradara.
This research focuses mainly on exploring the potential benefits of Chandanadi Basti and Pradarantaka Lauha in managing these interconnected conditions by improving hemoglobin level and effectively managing Menorrhagia. |