| CTRI Number |
CTRI/2026/02/103146 [Registered on: 06/02/2026] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study to evaluate the effect of Saptavarti Mahakalyanaka Ghrita in patients with anemia (Pandu disease). |
|
Scientific Title of Study
|
An Open labelled, Active Controlled, Randomized, Clinical Trial to Evaluate the Effect of
Saptavarti Mahakalyanaka Ghrita in the management of Pandu with special reference to
Megaloblastic Anemia. |
| 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 Priyanka Vaishnav |
| Designation |
PG Scholar |
| Affiliation |
Parul institute of ayurved |
| Address |
OPD no 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limda Tal Waghodiya Vadodara GUJARAT
Vadodara
GUJARAT
361760
India |
| Phone |
8849986819 |
| Fax |
|
| Email |
priyanka26012000vrps@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MANU R |
| Designation |
Professor |
| Affiliation |
Parul institute of ayurved |
| Address |
OPD no 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limda Tal Waghodiya Vadodara GUJARAT
Vadodara
GUJARAT
361760
India |
| Phone |
81608858967 |
| Fax |
|
| Email |
manu.r260022@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR MANU R |
| Designation |
Professor |
| Affiliation |
Parul institute of ayurved |
| Address |
OPD no 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limda Tal Waghodiya Vadodara GUJARAT
Vadodara
GUJARAT
361760
India |
| Phone |
81608858967 |
| Fax |
|
| Email |
manu.r260022@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Parul Institute of ayurved Parul university Ap-Limda Tal-Waghodia Dis-vadodara Gujarat India- 391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute of ayurved |
| Address |
Parul Institute of ayurved Parul university Ap-Limda Tal-Waghodia Dis-vadodara Gujarat India- 391760 |
| Type of Sponsor |
Private 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 PRIYANKA |
Parul Institute of ayurved |
OPD no 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limda Tal Waghodiya Vadodara GUJARAT
Vadodara
GUJARAT |
8849986819
priyanka26012000vrps@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul Institute Of Ayurved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D519||Vitamin B12 deficiency anemia, unspecified. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: mahakalynaka ghrita, Reference: astang hridaya uttaratantra, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 715(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: warm water), Additional Information: saptavarti gel capsules | | 2 | Comparator Arm (Non Ayurveda) | | - | Tab.methylcobalamin | route:oral
dosage Form:tablets
dose:500 mcg
frequency : od
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to the age group of 18 to 60 years of either gender irrespective of religion and socioeconomic status
Patients already diagnosed with Pandu as well as newly diagnosed cases of Pandu
Patients having serum vitamin B12 value less than 200 pg per mL
Patients having hemoglobin levels below normal values that is less than 13 percent in men and less than 12 percent in women according to WHO criteria for nutritional anemia
Patients having mean corpuscular volume value more than 100 femtoliter |
|
| ExclusionCriteria |
| Details |
Patients with a history of congenital disorders related to the haemopoietic system like SCA, leukaemia & haemophilia.
Patients with a history of other systemic diseases, like uncontrolled diabetes mellitus.
Patients suffering from disorders of the GIT system associated with gastrointestinal bleeding, like colorectal malignancy, peptic ulceration.
Pregnant and lactating women.
Immunocompromised Patients-HIV.
Patients who are currently participating in any other clinical trials (in the last 2 months) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Saptavarti Mahakalyanaka Ghrita in the management of Pandu with special reference to Megaloblastic Anemia. |
The primary outcome will be evaluated by comparing the mean change in serum Vitamin B12 levels and MCV values from baseline to Day 90 of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of Saptavarti Mahakalyanaka Ghrita based on the Fatigue assessment scale |
On 1st visit and 6th visit |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/02/2026 |
| 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 an open-labelled, randomized, active-controlled clinical trial designed to evaluate the efficacy of Saptaavarti Mahakalyanaka Ghrita in the management of Pandu Roga with special reference to Megaloblastic Anemia (Vitamin B12 deficiency anemia). Megaloblastic anemia results from impaired DNA synthesis due to Vitamin B12 deficiency, leading to macrocytic anemia and possible neurological complications, and it is correlated in Ayurveda with Pandu Roga characterized by pallor, weakness, and fatigue. A total of 60 patients aged 18–60 years with confirmed B12 deficiency (Serum B12 <200 pg/mL, MCV >100 fL, low Hb) will be randomly divided into two groups: the trial group receiving Saptaavarti Mahakalyanaka Ghrita and the control group receiving Methylcobalamin 500 mcg for 90 days. Assessment will be based on subjective parameters (Pandu symptoms and Fatigue Assessment Scale) and objective parameters (Serum B12 and CBC including MCV). The study follows AYUSH GCP guidelines, with ethical clearance and CTRI registration, aiming to scientifically evaluate and compare the effectiveness of this classical Ayurvedic formulation with standard Vitamin B12 therapy in managing megaloblastic anemia. |